- |||||||||| Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen
Cost-Effectiveness of Long-Term Medication Therapy for Obesity Management () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_523;
The availability of medications, including semaglutide, liraglutide, phentermine/topiramate, and bupropion/naltrexone, provide more options for chronic obesity management. Long-term medication therapy to manage obesity may provide individuals with opportunities for sustained weight loss; however, semaglutide and liraglutide would generally require discounted prices to become a cost-effective life-long obesity management strategy.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NRx Pharma, Alvogen
Trial primary completion date: MBD: NRX-101 for Bipolar Depression With Subacute Suicidal Ideation (clinicaltrials.gov) - Mar 8, 2023
P2, N=70, Recruiting,
Long-term medication therapy to manage obesity may provide individuals with opportunities for sustained weight loss; however, semaglutide and liraglutide would generally require discounted prices to become a cost-effective life-long obesity management strategy. Trial primary completion date: Dec 2022 --> Mar 2023
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
Enrollment open, Trial completion date, Trial primary completion date: SIC2: Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease (clinicaltrials.gov) - Mar 1, 2023
P=N/A, N=170, Recruiting,
Thus, our study established a critical role of FTO in both the insulin-regulated hepatic lipogenesis and the pathogenesis of NAFLD and provided a potential strategy for treating NAFLD. Not yet recruiting --> Recruiting | Trial completion date: Jun 2024 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Aug 2024
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Trial completion, Real-world evidence: This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry (clinicaltrials.gov) - Feb 24, 2023
P=N/A, N=255, Completed,
In summary, we generated a human liver-chip model using a standardized organ-chip platform which combines up to 100 spheroids and can be used for the evaluation of both drug safety and metabolism. Active, not recruiting --> Completed
- |||||||||| Review, Journal: Pharmacological Support for the Treatment of Obesity-Present and Future. (Pubmed Central) - Feb 12, 2023
The drugs whose weight-reducing effect is used in the course of the pharmacotherapy of other diseases (e.g., glucose-sodium cotransporter inhibitors, exenatide) are also worth mentioning...These trends also include an assessment of the usefulness of the weight-reducing properties of the drugs previously used for other diseases. The presented paper is an overview of the studies related to both drugs currently used in the pharmacotherapy of obesity and those undergoing clinical trials, taking into account the individual approach to the patient.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Zymfentra (infliximab-dyyb subcutaneous) / Celltrion
New trial: PRIME: IBD Disease Course of Infliximab-na (clinicaltrials.gov) - Feb 10, 2023
P=N/A, N=120, Not yet recruiting,
- |||||||||| Contrave (naltrexone/bupropion) / Currax, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen, Saxenda (liraglutide 3 mg) / Novo Nordisk
Trial completion, Trial completion date, Trial primary completion date: Individualized Obesity Pharmacotherapy (clinicaltrials.gov) - Feb 3, 2023
P3, N=200, Completed,
program could yield long-term cost savings for the Veterans Affairs network and meaningful clinical improvements for Veterans with obesity. Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> May 2022 | Trial primary completion date: Jul 2023 --> May 2022
- |||||||||| Hervelous (trastuzumab biosimilar) / Hanwha Solutions, Alvogen, Prestige BioPharma, Mundipharma, Dr. Reddy's
Clinical, P3 data, Clinical Trial,Phase III, Journal: Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting. (Pubmed Central) - Feb 2, 2023
P3
Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> May 2022 | Trial primary completion date: Jul 2023 --> May 2022 This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Comparing long-term outcomes in inflammatory bowel disease patients between switch and non-switch cohorts: no differences in infliximab persistence or safety outcomes after 54 months (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_1493;
Here we report long-term (>48 weeks) treatment outcomes of the SAME study, a large-scale parallel cohort study of Australian IBD patients who underwent non-medical switching from originator to biosimilar (CT-P13) (n=204) or continued originator infliximab (n=141).MethodsThe SAME study was a multi-centre, prospective parallel cohort non-inferiority study across seven Australian hospitals over 48 weeks undertaken between May 2017 to October 2019...There were no differences in the proportions that discontinued infliximab due to clinical or biochemical worsening of disease (21.7 v 23.6%, p = 0.72); required infliximab dose escalation (35.2 v 32.4%, p=0.8); developed antibodies to infliximab (5.3 vs 11.3%, p = 0.09) or experienced drug related adverse events (7.8 vs 8.3%, p = 0.8) between switch and non-switch cohorts, at last follow-up.ConclusionLong-term infliximab persistence was similar between switch and non-switch cohorts after a median of 54 months. This study represent one of the longest 'real-world' comparisons between switch and non-switch cohorts specific to IBD, and should provide reassurance to clinicians and patients alike.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_1485;
The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)...The number of switches was not independently associated with IFX persistence after adjusting for confounders (table 1). Clinical (p=0.77), biochemical (CRP ≤5mg/mL; p=0.75) and faecal biomarker (FC5mg/L at switch 2.96 1.34-6.54 0.007 3.21 1.43-7.24 0.005 FC ≥250 μg/gr at switch 1.57 0.52-4.69 0.40 IFX antibodies at switch 5.44 2.47-11.99 <0.0001 5.81 2.63-12.84 <0.0001 Variable Univariable Cox Regression Multivariable Cox Regression* Hazard Ratio 95% CI p Hazard Ratio 95% CI p Disease duration 0.79 0.56-1-11 0.17 Duration of IFX treatment 0.514 0.35-0.76 0.001 0.77 0.62-0.95 0.015 UC/IBDU versus CD 0.32 0.15-0.68 0.003 2.69 1.19-6.06 0.018 Perianal disease 1.61 0.56-4.66 0.38 Biologic/small molecule naïve 0.38 0.15-0.94 0.037 Number of switches 0.40 0.22-0.73 0.003 Clinical remission at switch 1.34 0.57-3.15 0.50 CRP >5mg/L at switch 2.96 1.34-6.54 0.007 3.21 1.43-7.24 0.005 FC ≥250 μg/gr at switch 1.57 0.52-4.69 0.40 IFX antibodies at switch 5.44 2.47-11.99 5mg/L at switch 2.96 1.34-6.54 0.007 3.21 1.43-7.24 0.005 FC ≥250 μg/gr at switch 1.57 0.52-4.69 0.40 IFX antibodies at switch 5.44 2.47-11.99 5mg/L at switch 2.96 1.34-6.54 0.007 3.21 1.43-7.24 0.005 FC ≥250 μg/gr at switch 1.57 0.52-4.69 0.40 IFX antibodies at switch 5.44 2.47-11.99 <0.0001 5.81 2.63-12.84 <0.0001 Open in new tab ConclusionMultiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Pre-treatment vitamin D concentrations do not predict therapeutic outcome to anti-TNF therapies in biologic-naïve patients with active luminal Crohn's disease (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_811;
25-hydroxyvitamin D concentrations were measured in stored baseline serum samples and cut-offs for vitamin D status were: deficiency 50nmol/L.ResultsSamples from 659/898 infliximab (526 Remicade; 133 biosimilar CT-P13) and 448/605 adalimumab (448 Humira) treated patients included in the effectiveness analysis of the PANTS study were included...At baseline, 22.2% (246/1107) patients were receiving some form of vitamin D supplementation.Multivariable linear regression analysis confirmed that baseline sampling during non-summer months (Figure 2), South Asian ethnicity, lower serum albumin concentrations, higher HBI and nontreatment with vitamin D supplements were independently associated with lower vitamin D concentrations (Figure 3).Primary non-response at week 14 and non-remission at week 54 occurred in 19.3% (116/600; 95% CI 16.4 - 22.7%) and 58.8% (351/597; 95% CI 54.8- 62.7%) patients treated with infliximab and 25.3% (100/396; 95% CI 21.2- 29.8%) and 65.3% (246/377; 95% CI 60.3- 69.9%) of patients treated with adalimumab, respectively.Pre-treatment vitamin D status did not predict response or remission status to anti-TNF therapy at week 14 (infliximab Ppnr = 0.87, adalimumab Ppnr = 0.18) or non-remission at week 54 (infliximab P = 0.12, adalimumab P = 0.59) (Figure 4).ConclusionVitamin D deficiency is common in patients with active Crohn's disease. Unlike previous studies, pre-treatment serum 25-hydroxyvitamin D concentration did not predict primary non-response to anti-TNF treatment at week 14 or non-remission at week 54.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Remsima SC (infliximab biosimilar SC) / Celltrion
Effect on direct and indirect costs of switching Inflammatory Bowel Disease patients from intravenous to subcutaneous infliximab (CT-P13) (Poster exhibition) - Feb 1, 2023 - Abstract #ECCOIBD2023ECCO_IBD_796;
See figure 2 for a breakdown of direct and indirect costs.ConclusionOur real-world analysis demonstrates that a switch from IV to SC CT-P13 is broadly cost neutral to the health service. Whilst the SC option has higher drug costs, a switch to SC allows for more efficient running of IV induction therapies by reducing demand on the infusion unit and reduces costs to the patient in terms of travel, parking and potential loss of working hours.
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen
Journal, Surgery, Bariatric surgery: Pharmacologic management of weight regain following bariatric surgery. (Pubmed Central) - Jan 27, 2023
Observational studies in the post-bariatric surgery population consistently demonstrate the benefit of medical weight management after bariatric surgery, with most evidence highlighting liraglutide, topiramate, and phentermine/topiramate. New anti-obesity medications are anticipated to be helpful for post-surgical weight optimization given their efficacy in the non-surgical population.
- |||||||||| Inflectra (infliximab-dyyb) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer
Enrollment closed, Real-world evidence: This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry (clinicaltrials.gov) - Dec 16, 2022
P=N/A, N=200, Active, not recruiting,
No abstract available Not yet recruiting --> Active, not recruiting
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp
Journal: Elucidating the function of hypothetical PE_PGRS45 protein of Mycobacterium tuberculosis as an oxido-reductase: a potential target for drug repurposing for the treatment of tuberculosis. (Pubmed Central) - Dec 1, 2022
Furthermore, in-vitro and in-vivo validation will aid in drug-resistant TB treatment. HIGHLIGHTSIn-silico and in-vitro studies of hypothetical protein PE_PGRS45 (Rv2615c) of Mycobacterium tuberculosis (Mtb) reveals it to be an integral membrane proteinPE_PGRS45 protein has substrate specificity for fatty acyl Coenzyme A (fatty acyl CoA) and possess NADPH dependent oxido-reductase activityDocking and simulation studies revealed that first line anti-tubercular drug Isoniazid (INH) and other drugs with anti-TB property have strong affinity for PE_PGRS45 proteinOxido-reductase activity of PE_PGRS45 protein is inhibited by INHPE_PGRS45 protein could be targeted by drugs that can be repurposed for TB treatmentCommunicated by Ramaswamy H. Sarma.
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp
Review, Journal: Mushroom Polysaccharides as Potential Candidates for Alleviating Neurodegenerative Diseases. (Pubmed Central) - Nov 27, 2022
Some have been demonstrated to exhibit neuroprotective effects via their antioxidant, anti-amyloidogenic, anti-neuroinflammatory, anticholinesterase, anti-apoptotic, and anti-neurotoxicity activities, which have potential in the treatment of NDs. This review focuses on the different processes involved in ND development and progression, highlighting the neuroprotective activities and potential role of mushroom polysaccharides and summarizing the limitations and future perspectives of mushroom polysaccharides in the prevention and treatment of NDs.
- |||||||||| Comtan (entacapone) / Novartis, Orion Corp
Journal: Correction to "Lymphocytic colitis associated with entacapone". (Pubmed Central) - Nov 17, 2022
As an implication, an acidic environment must be ensured when these drugs are applied, and generic exchange of levodopa combinations should be considered only with great caution. No abstract available
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen, Xenical (orlistat) / Roche, GSK
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: EMPOWER-T2D: EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial (clinicaltrials.gov) - Nov 4, 2022
P4, N=69, Active, not recruiting,
Trial completion date: Nov 2024 --> Feb 2025 | Initiation date: Oct 2022 --> Jan 2023 Recruiting --> Active, not recruiting | N=300 --> 69 | Trial completion date: Sep 2025 --> Mar 2023 | Trial primary completion date: Sep 2024 --> Aug 2022
- |||||||||| Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen
Review, Journal: Phentermine/Topiramate: Pediatric First Approval. (Pubmed Central) - Oct 27, 2022
Clinical development of phentermine/topiramate for sleep apnoea syndrome and type-2 diabetes in obese patients and preclinical development for NASH is ongoing in the US. This article summarizes the milestones in the development of phentermine/topiramate leading to this pediatric first approval for chronic weight management in adolescents.
- |||||||||| Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen, Xenical (orlistat) / Roche, GSK
Clinical guideline: AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity. (Pubmed Central) - Oct 25, 2022
This article summarizes the milestones in the development of phentermine/topiramate leading to this pediatric first approval for chronic weight management in adolescents. In adults with overweight and obesity who have an inadequate response to lifestyle interventions alone, long-term pharmacological therapy is recommended, with multiple effective and safe treatment options.
- |||||||||| Saxenda (liraglutide 3 mg) / Novo Nordisk
FDA event, Review, Journal: FDA-Approved Pharmacotherapy for Weight Loss Over the Last Decade. (Pubmed Central) - Oct 25, 2022
However, a massive obstacle in developing treatment guidelines remains the lack of prolonged studies monitoring the long-term safety and efficacy of obesity medications. Nevertheless, in patients at risk of complications from obesity, the benefits of losing fat mass may outweigh the potential side effects associated with these medications and clinicians should prescribe whichever of the FDA-approved pharmacotherapy they deem most appropriate for the patient's specific set of circumstances.
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