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- ||| Radicava (edaravone) / Mitsubishi Tanabe
P3 data, Retrospective data, Journal: Efficacy of Radicava (Pubmed Central) - Dec 12, 2024
This post hoc analysis suggests MTPA IV edaravone treatment results in slower ALSFRS-R decline vs placebo in most predicted nonlinear trajectories. LCA is a novel approach that may benefit future trial analyses.
- Preliminary analysis of treatment combinations in patients with amyotrophic lateral sclerosis enrolled in an US-based administrative claims database (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_625;
Patients with ALS continuously enrolled in Optum's de-identified ClinformaticsV R Data Mart (CDM) from 1 August 2017, through 30 September 2023, were included (intravenous) and Radicava ORSV and grouped based on ALS treatment combination... Patients were grouped based on use of riluzole only (n = 2193) vs. other FDA approved treatment/treatment combinations (n = 967) including Mitsubishi Tanabe Pharma America (MTPA) edaravone, PB-TURSO, riluzole
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Evolution of the treatment landscape for patients diagnosed with ALS in the United States (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_624;
Mitsubishi Tanabe Pharma America (MTPA) IV edaravone was introduced in 2017 and saw a consistent increase from 1 to 4.8% between 2017 and 2021. However, with the introduction of oral edaravone in 2022, the use of IV edaravone decreased to 1%, while the use of oral edaravone increased to 8.9%.
- Relyvrio (phenylbutyrate/taurursodiol) / Amylyx, Radicava (edaravone) / Mitsubishi Tanabe
Canadian regulatory framework and flexibility in the context of rare diseases with unmet medical need such as amyotrophic lateral sclerosis (ALS) (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_611;
Access to ALS Therapies in Canada: There are currently two available ALS treatments in Canada: RADICAVA (edaravone) and RILUTEK (riluzole)... HC follows rigorous scientific and regulatory processes for drug approval, while exercising flexibility within the regulatory framework to respond to the pressing need for rare diseases therapies, including ALS, for Canadian patients.
- Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3, open-label, safety extension study of oral edaravone (Radicava ORSV R ) administered over 96 weeks in patients with ALS (MT-1186-A03) (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_600;
P3
The most common treatment-emergent adverse events (TEAEs) were fall, muscular weakness, dyspnea, constipation, and dysphagia. These TEAEs were consistent with the safety profile for edaravone from previous clinical trials.
- Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3b study MT-1186-A02 to investigate the superiority of daily dosing vs the FDA-approved on/off regimen of oral edaravone (Radicava ORSV R )in patients with ALS (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_599;
P3b
Oral edaravone was well tolerated and no new safety concerns were identified in either group in Study MT-1186-A02. Daily oral edaravone did not show superiority to the FDA-approved on/off regimen in the CAFS, and was comparable in safety, efficacy, and tolerability to the on/off dosing regimen, therefore reinforcing the appropriateness of the FDA-approved regimen.
- Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3b Study MT-1186-A04 Extension Study to Evaluate the Continued Efficacy and Safety of Radicava ORSV R (Oral Edaravone) for up to an Additional 48-Weeks in Patients With Amyotrophic Lateral Sclerosis (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_598;
P3b
Oral edaravone was well tolerated and no new safety concerns were identified in either group in Study MT-1186-A04. Similar to the results obtained in MT-1186-A02, in MT-1186-A04, daily Radicava ORSV R did not show superiority to the FDA-approved on/off regimen (same safety, efficacy and tolerability profile) from the time of the randomization date in Study MT-1186-A02 to at least a 12-point decrease in ALSFRS-R or death, whichever happened first, and reinforces the appropriateness of the FDA-approved regimen.
- Bosulif (bosutinib) / Pfizer
Clinical trial of bosutinib for amyotrophic lateral sclerosis: induced pluripotent stem cell-based Drug Repurposing for Amyotrophic Lateral Sclerosis Medicine (iDReAM) study (Poster Hall at the Palais de Congres Montreal; 517b/c) - Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_586;
No new safety concerns were identified on 24-week treatment of bosutinib in patients with ALS. Three out of four efficacy endpoints were met in the efficacy analysis.
- || Bosulif (bosutinib) / Pfizer
Clinical protocol, P2 data, Journal, Real-world evidence, Real-world: Protocol for a phase 2 study of bosutinib for amyotrophic lateral sclerosis using real-world data: induced pluripotent stem cell-based drug repurposing for amyotrophic lateral sclerosis medicine (iDReAM) study. (Pubmed Central) - Oct 27, 2024
P1/2
The findings will be disseminated in peer-reviewed journals and at scientific conferences. jRCT2051220002; Pre-results, NCT04744532; Pre-results.
- Radicava (edaravone) / Mitsubishi Tanabe
Treatment patterns and survival benefit of edaravone-treated people with ALS in the ALS/MND Natural History Consortium (517D) - Oct 1, 2024 - Abstract #ALSMND2024ALS_MND_19;
Radicava ORSV R (edaravone) oral suspension was FDA approved in 2022... Patients receiving edaravone
- Development of Edaravone tablets for the treatment of Alzheimer's disease---Phase I trials in healthy volunteers and Phase II design in early AD () - Sep 24, 2024 - Abstract #CTAD2024CTAD_406;
- || Radicava (edaravone) / Mitsubishi Tanabe, FR 167653 / Astellas
Review, Journal: Postoperative Intimal Hyperplasia: Review from My Research. (Pubmed Central) - Aug 12, 2024
suppressive agent, inhibitor of p 38 mitogen-activated protein kinase; Fujisawa Pharmaceutical Co., Ltd., Japan) is found to suppress postoperative intimal hyperplasia in a rat model by reducing serum monocyte chemoattractant protein-1 levels...Because endothelial injury is the first step of postoperative intimal hyperplasia, I investigated whether the free radical scavenger, edaravone (Radicut, Mitsubishi Tanabe Pharma Co., Japan), which alleviates the endothelial injury in vitro , can also suppress postoperative intimal hyperplasia...Hepatocyte growth factor is not only a hepatic growth factor but also a vascular endothelial growth factor. Recently, serum hepatocyte growth factor level was found to be a candidate biomarker for postoperative intimal hyperplasia in our rat model.
- || Review, Journal: Assessing the efficacy of amyotrophic lateral sclerosis drugs in slowing disease progression: A literature review. (Pubmed Central) - Jul 11, 2024
These FDA-sanctioned treatments are Qalsody, Relyvrio, Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta...However, despite these advancements in pharmaceutical interventions, finding a definitive cure for ALS remains a significant challenge. Continuous investigation into ALS pathophysiology and therapeutic avenues remains imperative, necessitating further research collaborations and innovative approaches to unravel the complex mechanisms underlying this debilitating condition.
- | Radicava (edaravone) / Mitsubishi Tanabe
Journal: The Antioxidant Drug Edaravone Binds to the Aryl Hydrocarbon Receptor (AHR) and Promotes the Downstream Signaling Pathway Activation. (Pubmed Central) - Apr 27, 2024
Among drugs with free radical scavenging activity and oligodendrocyte protecting effects, Edaravone (Radicava) has recently received increasing attention because of being able to enhance remyelination in experimental in vitro and in vivo disease models...We finally demonstrate that its rapid cytoprotective and antioxidant actions boost increased expression of the promyelinating Olig2 protein as well as of an Olig2:GFP transgene in vivo. We therefore shed light on a still undescribed potential mechanism of action for this drug, providing further support to its therapeutic potential in the context of debilitating demyelinating conditions.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Health care resource utilization of oral edaravone () - Apr 9, 2024 - Abstract #AMCP2024AMCP_109;
BACKGROUND: Intravenous (IV) edaravone (Radicava) was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of amyotrophic lateral sclerosis (ALS) and was shown in clinical trials to slow the rate of physical functional decline. These real-world data may help clinicians and payers better understand the demographics, clini- cal characteristics, and HCRU of oral edaravone
- || edaravone oral (TTYP01) / Auzone Biological
Trial completion, Trial completion date: Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - Mar 25, 2024
P1, N=29, Completed, Sponsor: Auzone Biological Technology Pty Ltd
These real-world data may help clinicians and payers better understand the demographics, clini- cal characteristics, and HCRU of oral edaravone Recruiting --> Completed | Trial completion date: May 2024 --> Dec 2023
- || Radicava (edaravone) / Mitsubishi Tanabe
Review, Journal: Update on Antioxidant Therapy with Edaravone: Expanding Applications in Neurodegenerative Diseases. (Pubmed Central) - Mar 17, 2024
Edaravone (MCI-186, 3-methyl-1 pheny-2-pyrazolin-5-one), a free radical scavenger, has promising effects by quenching hydroxyl radicals (?OH) and inhibiting both ?OH-dependent and ?OH-independent lipid peroxidation...Data from experimental animal models support its safety for long-term use, implying broader applications in various neurodegenerative diseases. In this review, we explain the unique characteristics of edaravone, summarize recent findings for specific diseases, and discuss its prospects for future therapeutic applications.
- Radicava (edaravone) / Mitsubishi Tanabe
Pharmacological modulation of autophagy prevents mutant Sod1g93a induced neurotoxicity in experimental models of amyotrophic lateral sclerosis (ALS) | Poster Board #1902 (In-person; Poster Board #1902; Hall C (Ernest N. Morial Convention Center)) - Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_3005;
Finally, we demonstrated that IADB treatment could improve motor performance and delay the onset and progression of the disease in a mouse model of ALS. The neuroprotective effects of IADB may mainly originate from its autophagy-promoting property.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
A Preliminary Analysis of Oral Edaravone-Treated Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_400;
The neuroprotective effects of IADB may mainly originate from its autophagy-promoting property. OBJECTIVES: Intravenous (IV) edaravone (Radicava
- Relyvrio (phenylbutyrate/taurursodiol) / Amylyx, Radicava (edaravone) / Mitsubishi Tanabe
Amyotrophic Lateral Sclerosis (ALS) in Puerto Rico: An Overview (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3537;
The CELA-PR allowed to develop the first database for ALS in Puerto Rico and get an overview of the descriptive epidemiology of ALS. Although some similarities with the reported data in USA were found this study provides a detailed description of the characteristics of our ALS population as well as valuable information of their pattern of care.
- Radicava (edaravone) / Mitsubishi Tanabe
Real-world Evidence on Treatment Retention, Safety, and Tolerability of Edaravone in Canadian Patients with Amyotrophic Lateral Sclerosis (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3128;
Although some similarities with the reported data in USA were found this study provides a detailed description of the characteristics of our ALS population as well as valuable information of their pattern of care. Objective:To determine real-world treatment retention, safety, and tolerability from edaravone-treated patients with amyotrophic lateral sclerosis (ALS) in the MTP-Patient Support
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
A Preliminary Analysis of Oral Edaravone-treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-based Administrative Claims Database (Colorado Convention Center | Four Seasons 2/3) - Mar 8, 2024 - Abstract #AAN2024AAN_2358;
Objective:To determine real-world treatment retention, safety, and tolerability from edaravone-treated patients with amyotrophic lateral sclerosis (ALS) in the MTP-Patient Support Background:Intravenous (IV) edaravone (Radicava
- | Radicava (edaravone) / Mitsubishi Tanabe
Journal: High-density lipoprotein protects vascular endothelial cells from indoxyl sulfate insults through its antioxidant ability. (Pubmed Central) - Jan 22, 2024
L-NAME and MCI186 were used as a nitric oxide synthase inhibitor and a free radical scavenger, respectively...In conclusion, HDL exerted a comprehensive protective effect on vascular endothelial cells against damage from IS through its antioxidant ability. The results of this study might provide a theoretical basis for potential HDL supplementation in CKD patients with endothelial damage.
- Radicava (edaravone) / Mitsubishi Tanabe
A Meta-analysis of inclusion/ exclusion criteria in interventional Amyotrophic Lateral Sclerosis (ALS) clinical trials and its impact on recruitment (Event Halle, Messe Basel, Ground Floor) - Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_465;
ALSFRS was mentioned in one third of trials, although the use of this scale as an eligibility criterion varied. 41% of trials mentioned the use of conjunctive therapies and the required washout periods of Edaravone and Radicava are further analyzed.
- Radicava (edaravone) / Mitsubishi Tanabe
Interim Analysis of the Radicava/ Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (Event Halle, Messe Basel, Ground Floor) - Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_457;
Biomarker and clinical data from this interim analysis will be presented. Results from this ongoing study may help to identify prognostic and disease monitoring markers of ALS and predictive and pharmacodynamic biomarkers of edaravone effect.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
A Preliminary Analysis of Oral Edaravone-Treated Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Event Halle, Messe Basel, Ground Floor) - Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_304;
Oral edaravone-treated patients with ALS (n = 231) consisted of 59 patients in Group 1 and 172 patients in Group 2. Group 1 and Group 2 were predominantly male (59.3 and 58.7%), White (72.9 and 77.3%), from the southern US (39.0 and 40.1%), and covered by Medicare (69.5% and 59.3%), with a mean
- || edaravone oral (TTYP01) / Auzone Biological
New P1 trial: Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - Oct 29, 2023
P1, N=30, Recruiting, Sponsor: Auzone Biological Technology Pty Ltd
- || Radicava (edaravone) / Mitsubishi Tanabe
Biomarker, Enrollment closed, Trial completion date, Trial primary completion date: Radicava (clinicaltrials.gov) - Aug 24, 2023
P=N/A, N=300, Active, not recruiting, Sponsor: Mitsubishi Tanabe Pharma America Inc.
Group 1 and Group 2 were predominantly male (59.3 and 58.7%), White (72.9 and 77.3%), from the southern US (39.0 and 40.1%), and covered by Medicare (69.5% and 59.3%), with a mean Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
- || Qalsody (tofersen) / Biogen, MSC-NTF / BrainStorm Cell Therap, Radicava (edaravone) / Mitsubishi Tanabe
#Tofersen is a step in the right direction! But I am #ALS Bulbar. I was one of the first to go on #Radicava! #NurOwn next? Don't force me to make a exit plan! #EndALS #EverySecondCounts @iamalsorg @alsassociation @ALSAMichigan (Twitter) - May 1, 2023
- Radicava (edaravone) / Mitsubishi Tanabe
Treatment Outcomes for Patients With Amyotrophic Lateral Sclerosis Receiving Intravenous Edaravone From a Home and Alternative-Site Infusion Provider (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_2491;
Conclusions This analysis describes treatment outcomes in IV edaravone-treated patients with ALS in a real-world setting. This information may be useful to clinicians who prescribe IV edaravone for patients with ALS.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (MT-1186-A01): 48-Week Results (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_2487;
P3
This information may be useful to clinicians who prescribe IV edaravone for patients with ALS. Background An intravenous (IV) formulation of edaravone (Radicava
- | Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Journal: Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. (Pubmed Central) - Dec 13, 2022
Background An intravenous (IV) formulation of edaravone (Radicava This study indicated that oral edaravone was well tolerated during 48 weeks of treatment, with no new safety concerns identified.
- || Teglutik (riluzole oral suspension) / Italfarmaco, Exservan (riluzole oral soluble film) / Aquestive, Zambon, Mitsubishi Tanabe, Radicava (edaravone) / Mitsubishi Tanabe
Review, Journal: Biological aspects of nitrogen heterocycles for amyotrophic lateral sclerosis. (Pubmed Central) - Dec 9, 2022
• Neurodegenerative diseases and their drawbacks are discussed in detail. • Recent survey of nitrogen heterocycles in treating ALS disease are highlighted.
- | Relyvrio (phenylbutyrate/taurursodiol) / Amylyx
Journal: Relyvrio for ALS. (Pubmed Central) - Nov 19, 2022
• Recent survey of nitrogen heterocycles in treating ALS disease are highlighted. No abstract available
- | Radicava (edaravone) / Mitsubishi Tanabe
Preclinical, Journal: Effect of MCI-186 on Lipid Peroxidation in Experimental Traumatic Brain Damage in Rats. (Pubmed Central) - Nov 19, 2022
Reactive oxidation products significantly decreased in the MCI-186 group. Thus, MCI-186 can be used as a free radical-binding agent in traumatic brain damage.
- || Radicava (edaravone) / Mitsubishi Tanabe
PK/PD data, Journal: Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants. (Pubmed Central) - Nov 17, 2022
P1
Oral administration of edaravone with a meal decreased the plasma concentration of edaravone. Oral administration of edaravone 8 hours after a high-fat meal, 4 hours after a low-fat meal, 2 hours after a light meal, and 1 hour before a high-fat meal showed no effect of food on the PK profile of unchanged edaravone compared with that observed under a fasted condition.
- | Radicava (edaravone) / Mitsubishi Tanabe
Retrospective data, Journal: Associations between the ALSFRS-R score and urate levels during 12 months of edaravone treatment for amyotrophic lateral sclerosis: Post hoc analysis of ALSFRS-R scores in clinical studies MCI186-16, MCI186-17, and MCI186-19. (Pubmed Central) - Oct 21, 2022
Edaravone treatment in ALS patients diagnosed with "definite ALS" or "probable ALS" showed slowing of disease progression, regardless of baseline urate level. In addition, because edaravone treatment was associated with a slower decline in urate level in the higher baseline urate subgroup and urate-level changes were associated with changes in ALSFRS-R score, urate level, and/or change may be one indicator in predicting disease progression after edaravone administration.
- | Radicava (edaravone) / Mitsubishi Tanabe
Retrospective data, Journal: Associations between urate levels and amyotrophic lateral sclerosis functional score with edaravone treatment: Post hoc analysis of studies MCI186-16, MCI186-17, and MCI186-19. (Pubmed Central) - Oct 21, 2022
In addition, because edaravone treatment was associated with a slower decline in urate level in the higher baseline urate subgroup and urate-level changes were associated with changes in ALSFRS-R score, urate level, and/or change may be one indicator in predicting disease progression after edaravone administration. This post hoc analysis indicated that ALS patients, including those with advanced ALS severity grades, may receive benefit in the group of patients whose urate levels are stable during the course of the edaravone treatment.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3b, Multicenter, Randomized, DoubleBlind, Parallel-Group Study Evaluating Efficacy and Safety of Investigational Oral Edaravone Administered over 48 Weeks in Patients with Amyotrophic Lateral Sclerosis () - Oct 17, 2022 - Abstract #ANA2022ANA_608;
Background : An IV formulation of edaravone (Radicava®/ Radicut) was shown to slow the rate of physical functional decline in ALS. This study will provide important information on the safety, efficacy, and tolerability of two dosing regimens for oral edaravone in patients with ALS.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3, Open-Label, Safety Extension Study of Investigational Oral Edaravone Administered over 96 Weeks in Patients with ALS (MT-1186-A03) () - Oct 17, 2022 - Abstract #ANA2022ANA_607;
Background : Radicava® (edaravone injection) is a US FDAapproved treatment for amyotrophic lateral sclerosis (ALS), shown to slow the rate of physical functional decline. This extension study will provide important information on the continued long-term safety and tolerability of this investigational oral formulation of edaravone in patients with ALS.
- Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Patients with Amyotrophic Lateral Sclerosis (MT-1186-A01): 48-Week Results () - Oct 17, 2022 - Abstract #ANA2022ANA_606;
Background : An intravenous (IV) formulation of edaravone (Radicava®/Radicut) has been shown to slow the rate of physical functional decline in amyotrophic lateral sclerosis (ALS). This study demonstrates that oral edaravone was generally safe and well tolerated during 48 weeks of treatment, with no new safety concerns identified.
- || Radicava (edaravone) / Mitsubishi Tanabe
P1 data, Journal: Edaravone Administered Orally and Via Nasogastric Tube in Healthy Adults: A Comparative Bioavailability Phase 1 Study. (Pubmed Central) - Oct 14, 2022
No serious adverse events or adverse drug reactions were reported. These results suggest that oral edaravone suspension can be administered directly to the stomach without dose adjustment via feeding tubes; both oral and NGT administration are well tolerated.
- Withdrawn (SDCC Halls B-H) - Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_13271;
These results suggest that oral edaravone suspension can be administered directly to the stomach without dose adjustment via feeding tubes; both oral and NGT administration are well tolerated. Grant Support: Translational Research Impacting Useful and Meaningful Precision Health (TRIUMPH) Initiative Missouri-Columbia School of Medicine to CMC, Summer Research Fellowship program at the University of Missouri-Columbia School of Medicine to JP and BG
- | Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Journal: In brief: Edaravone oral suspension (Radicava ORS) for ALS. (Pubmed Central) - Sep 20, 2022
Grant Support: Translational Research Impacting Useful and Meaningful Precision Health (TRIUMPH) Initiative Missouri-Columbia School of Medicine to CMC, Summer Research Fellowship program at the University of Missouri-Columbia School of Medicine to JP and BG No abstract available
- | Radicava (edaravone) / Mitsubishi Tanabe
Launch US, Journal: Analysis of the US Safety Data for Edaravone (Radicava) From the Third Year After Launch. (Pubmed Central) - Sep 10, 2022
No abstract available In the postmarketing reporting to date, no new safety signals were identified beyond those already known from the edaravone clinical trial program.
- | Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
Journal: New Oral Form for ALS Drug. (Pubmed Central) - Sep 2, 2022
The Food and Drug Administration has approved an oral suspension form of edaravone (Radicava ORS) for the treatment of amyotrophic lateral sclerosis.Edaravone should be taken on an empty stomach in the morning either by mouth or through a feeding tube. Feeding tubes should be flushed before and after drug administration.
- | Radicava (edaravone) / Mitsubishi Tanabe
Retrospective data, Journal: Intravenous edaravone treatment in ALS and survival: An exploratory, retrospective, administrative claims analysis. (Pubmed Central) - Aug 14, 2022
Propensity score matching identified IV edaravone-treated patients (cases) and non-edaravone-treated patients (controls) matched for covariates: age, race, geographic region, sex, pre-index disease duration, insurance, history of cardiovascular disease, riluzole prescription, gastrostomy tube placement, artificial nutrition, noninvasive ventilation, and all-cause hospitalisation...Data from adequately powered RCTs are needed to support this finding. Funded by Mitsubishi Tanabe Pharma America.
- || Zolgensma (onasemnogene abeparvovec-xioi) / Novartis, Radicava (edaravone) / Mitsubishi Tanabe
Biomarker: We keep doing the same things . Fast progressors , short trials. No early intervention. No longer trials. No embracement of biomarkers. Pharma hoping for another radicava instead of a zolgensma. (Twitter) - Aug 8, 2022
- || Radicava (edaravone) / Mitsubishi Tanabe
Review, Journal, HEOR: Quantifying the Value of Introducing an Oral Drug Delivery Option for Edaravone: A Review of Analyses Evaluating the Economic Impact of Oral versus Intravenous Formulations. (Pubmed Central) - Aug 6, 2022
We found significant design variations in published models that estimated the impact of an additional formulation option on the treatment costs to payers and the society. Models need to be accompanied with clear descriptions on rationales for their time horizons and assumptions on how different formulations may affect healthcare costs from the selected perspectives.
- | Radicava (edaravone) / Mitsubishi Tanabe
Retrospective data, Journal: Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. (Pubmed Central) - Jun 22, 2022
P3
ALS subjects in the Study 19 placebo arm had a slowing in disease progression, even when edaravone was added with an FVC of <80%p prior to starting edaravone. A randomized, placebo-controlled study is needed to validate these post-hoc findings.