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20 Trials |  |
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- | Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Osteoporosis: Romosozumab to rebuild the foundations of bone strength. (Pubmed Central) - Aug 15, 2019
No abstract available
- | abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Current Status of Bone-Forming Therapies for the Management of Osteoporosis. (Pubmed Central) - Aug 15, 2019
The BMD response to bone-forming treatment is reduced in patients previously treated with antiresorptive drugs; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with antiresorptives seems to be preserved. This review provides an overview of the existing bone-forming therapies for osteoporosis including considerations of sequential and combination therapy.
- ||| Evenity (romosozumab) / Astellas, Amgen, UCB
A new drug Evenity is on market for that. A new trial needed. I have to ask; how do doctors think about bone cement? It’s useful material but it’s a chemical at last and Myeloma doesn’t like chemicals. What’s general opinion about these cements? @SagarLonialMD (Twitter) - Aug 11, 2019
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab (Evenity) for postmenopausal osteoporosis. (Pubmed Central) - Aug 6, 2019
This review provides an overview of the existing bone-forming therapies for osteoporosis including considerations of sequential and combination therapy. No abstract available
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: New strategies for the prevention and treatment of systemic and local bone loss; from pathophysiology to clinical application. (Pubmed Central) - Aug 1, 2019
Other new strategies for the prevention and treatment of bone loss include calcilytics, cathepsin K inhibitor or the combination or the sequential use of the current drugs. New insights concerning the treatment of the local bone loss in RA and in Complex Regional Pain Syndrome type I are also provided in this review.
- | Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Antibodies to watch in 2019. (Pubmed Central) - Aug 1, 2019
In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
- | Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion, Head-to-Head: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (clinicaltrials.gov) - Jul 30, 2019
P3, N=283, Completed, Sponsor: Amgen
We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series. Active, not recruiting --> Completed
- ||||| Evenity (romosozumab) / Astellas, Amgen, UCB
European regulatory: Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a negative opinion on Application for romosozumab (Evenity) for the treatment of severe osteoporosis (by Amgen & UCB); an appeal is planned https://t.co/EVjxuBQdF0 (Twitter) - Jul 28, 2019
- | abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Current and emerging osteoporosis pharmacotherapy for women: state of the art therapies for preventing bone loss. (Pubmed Central) - Jul 26, 2019
Abaloparatide, a parathyroid-hormone-related peptide (PTHrP)-analogue, approved by the FDA in April 2017, constitutes the first new anabolic osteoporosis drug in the US for nearly 15 years and has also proven its anti-fracture efficacy. Romosozumab, a sclerostin inhibitor, which induces bone formation and suppresses bone resorption, has also been developed and shown a significant reduction in fracture incidence; however, concerns have arisen with regard to increased cardiovascular risk.
- ||| Evenity (romosozumab) / Astellas, Amgen, UCB
@Myeloma_Doc Professor I'm so glad that you share an article about bone health. I have 2 questions on that matter. Firstly, a new drug, Evenity (romosozumab-aqqg) is on market and it's said to be very good in building new bones at spine and hip. This can be very useful about (Twitter) - Jul 23, 2019
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Bone Loss After Romosozumab/Denosumab: Effects of Bisphosphonates. (Pubmed Central) - Jul 19, 2019
In the zoledronate group, mean PINP 6 months post-FRAME was 23 ± 4 µg/L and at 12 months it was 47 ± 8 µg/L, suggesting that repeat zoledronate dosing is needed at 1 year to maintain the BMD gains. In conclusion, delaying administration of intravenous bisphosphonate when transitioning from short-term denosumab appears to increase the extent to which the gains in BMD are maintained.
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Bone diseases: Romosozumab - on track or derailed? (Pubmed Central) - Jul 4, 2019
In conclusion, delaying administration of intravenous bisphosphonate when transitioning from short-term denosumab appears to increase the extent to which the gains in BMD are maintained. No abstract available
- | Journal: Pharmaceutical Approval Update. (Pubmed Central) - Jul 3, 2019
No abstract available Mavenclad (cladribine) tablets for relapsing MS forms; Duaklir Pressair (aclidinium bromide/formoterol fumarate) inhalant for COPD; Evenity (romosozumab-aqqg) injection for osteoporosis.
- || Evenity (romosozumab) / Astellas, Amgen, UCB
EU OKs Liraglutide in Kids; Rejects Romosozumab for Osteoporosis https://t.co/sfv0V866Pk via @medscape (Twitter) - Jul 1, 2019
- || Evenity (romosozumab) / Astellas, Amgen, UCB
Sin embargo la EMA acaba de decir NO https://t.co/IK9bmPWi2d #Osteoporosis @EMA_News #Romosozumab (Twitter) - Jun 29, 2019
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Amgen/UCB To Appeal EMA’s 'Over Cautious' Evenity Rejection https://t.co/Ow7us8a2NP #PinkSheet (Twitter) - Jun 28, 2019
- || Evenity (romosozumab) / Astellas, Amgen, UCB
European regulatory: Romosozumab Among Latest Drugs Up For CHMP Opinion https://t.co/5DD4uSbBwn #PinkSheet (Twitter) - Jun 25, 2019
- |||| Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical: We have a new agent; Evenity. We need trials on this one. Especially it’s use with maintenance? @VincentRK @NoopurRajeMD @SagarLonialMD @IreneGhobrial @AuclairDan @mtmdphd @alexis__talbot @nycdoc29 @IMFmyeloma @MyelomaTeacher @grpetersen1 @NorthTxMSG @IMFjimMYELOMA (Twitter) - Jun 16, 2019
- | abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Bone: best papers of the year 2017. (Pubmed Central) - Jun 15, 2019
Mavenclad (cladribine) tablets for relapsing MS forms; Duaklir Pressair (aclidinium bromide/formoterol fumarate) inhalant for COPD; Evenity (romosozumab-aqqg) injection for osteoporosis. These papers offer a hopeful outlook for a better treatment and management of patients with osteoporosis and other metabolic bone diseases anno 2018.
- | Evenity (romosozumab) / Astellas, Amgen, UCB, Mayzent (siponimod) / Novartis, Sunosi (solriamfetol) / Jazz
CMC Review Update: Evenity Sequence Variants, Sunosi Split-Tablet Risks, Mayzent Particle Size https://t.co/Kx59OHpeJP #PinkSheet (Twitter) - Jun 4, 2019
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, P3 data, Journal: A Phase 3 Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. (Pubmed Central) - May 29, 2019
P3
Adverse events and serious adverse events were balanced between groups, with a numerical imbalance in positively adjudicated cardiovascular serious adverse events (romosozumab 8 [4.9%] vs placebo 2 [2.5%]). Treatment with romosozumab for 12 months increased spine and hip BMD compared with placebo and was well tolerated in men with osteoporosis.
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Retrospective data, Journal: Romosozumab treatment in postmenopausal women with osteoporosis: a meta-analysis of randomized controlled trials. (Pubmed Central) - May 24, 2019
In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment resulted in a significantly lower risk of fracture. Romosozumab 210 mg monthly showed the largest gains in BMD, and was generally well tolerated.
- | Evenity (romosozumab) / Astellas, Amgen, UCB
New Drug Trials Snapshot available for Evenity (romosozumab-aqqg): https://t.co/grlkQhcXgV. View PI at: https://t.co/9T6yrZQS0R. (Twitter) - May 8, 2019
- | abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Molecular understanding of pharmacological treatment of osteoporosis. (Pubmed Central) - May 7, 2019
Cite this article: EFORT Open Rev 2019;4:158-164. DOI: 10.1302/2058-5241.4.180018.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, Actonel (risedronate) / Sanofi
Journal: Osteoporosis (Pubmed Central) - Apr 30, 2019
Atypical femoral fractures associated with bisphosphonate treatment could be more frequent in patients with particular anatomical features. Management of osteoporosis treatment depends on the drug which is used and on the risk of fracture of the patient.
- || Evenity (romosozumab) / Astellas, Amgen, UCB
Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs https://t.co/4jvgx0ykZr #PinkSheet (Twitter) - Apr 23, 2019
- |||||| Evenity (romosozumab) / Astellas, Amgen, UCB
FDA event, Pricing: The price of new osteoporosis drug Evenity (romosuzumab; sclerostin inhibitor) is $1,825/mo. or $21,900/Yr; Just FDA approved for post-menopausal OP at high risk for Fx . Amgen estimates Evenity to be 34-74% lower than Tymlos & Forteo. https://t.co/lYHyukTRPw (Twitter) - Apr 16, 2019
- | Evenity (romosozumab) / Astellas, Amgen, UCB, Keytruda (pembrolizumab) / Merck (MSD), Balversa (erdafitinib) / J&J, Otsuka
Keeping Track: NME Approvals For Evenity And Balversa; Non-NME Approvals For Dovato And Keytruda; But An RTF For Fintepla https://t.co/bI5dTEwDNz #PinkSheet (Twitter) - Apr 14, 2019
- ||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Antibody targeting Sclerostin, great for bones, but a serious CV risk signal. Didn’t “experts say” bone health is tied to CV health? Once spurned, Amgen wins the FDA over with its bone-building osteoporosis drug Evenity - https://t.co/4t2gerSP7p (Twitter) - Apr 10, 2019
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal: Evaluation of cross-sectional and longitudinal changes in volumetric bone mineral density in postmenopausal women using single- versus dual-energy quantitative computed tomography. (Pubmed Central) - Apr 9, 2019
Although our findings are based on normal aging, recent evidence from animal studies demonstrates that the skeletal anabolic drugs teriparatide and romosozumab may markedly reduce marrow fat, perhaps accounting for the disproportionate increases in trabecular vBMD by SE QCT as compared to dual-energy X-ray absorptiometry with these agents. As such, future studies using recently available DE scanning technology that has satisfactory precision and radiation exposure are needed to evaluate changes in trabecular vBMD independent of changes in marrow fat with aging and drugs that may alter marrow fat composition.
- ||||| Evenity (romosozumab) / Astellas, Amgen, UCB
FDA event: .@US_FDA approves new treatment for osteoporosis in postmenopausal ♀️at ⬆️risk of fracture.Evenity is a mAB that blocks sclerostin and works mainly by increasing new bone formation Warning: it may ⬆️the risk of heart attack, stroke and CV death #medtwitter https://t.co/Q1nrP3REY6 (Twitter) - Apr 9, 2019
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Anabolic Therapies in Osteoporosis and Bone Regeneration. (Pubmed Central) - Apr 5, 2019
The identification and development of therapeutic approaches modulating bone formation, rather than bone resorption, fulfils an essential clinical need, as treatment options for reversing bone loss and promoting bone regeneration are limited. This review focuses on currently available and future approaches that may have the potential to achieve these aims.
- ||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed, Head-to-Head: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (clinicaltrials.gov) - Oct 18, 2018
P3, N=260, Active, not recruiting, Sponsor: Amgen
This review focuses on currently available and future approaches that may have the potential to achieve these aims. Recruiting --> Active, not recruiting
- | Tymlos (abaloparatide) / Radius, Teijin, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Osteoanabolic Agents for Osteoporosis. (Pubmed Central) - Aug 9, 2018
The sequence of administration of anabolic therapy is important. Benefits of anabolics are attenuated in individuals with prior antiresorptive exposure; however, antiresorptive agents administered after anabolics consolidate bone mineral density gains.
- ||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion: A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis (clinicaltrials.gov) - May 30, 2018
P3, N=67, Completed, Sponsor: Amgen
Benefits of anabolics are attenuated in individuals with prior antiresorptive exposure; however, antiresorptive agents administered after anabolics consolidate bone mineral density gains. Active, not recruiting --> Completed
- |||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open, Phase classification, Head-to-Head: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (clinicaltrials.gov) - Mar 13, 2018
P3, N=260, Recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Withheld --> Recruiting | Phase classification: PN/A --> P3
- |||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial primary completion date: A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis (clinicaltrials.gov) - Mar 3, 2018
P3, N=67, Active, not recruiting, Sponsor: Amgen
Withheld --> Recruiting | Phase classification: PN/A --> P3 Trial primary completion date: Feb 2018 --> Feb 2018
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
New P3 trial, New trial, Head-to-Head: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (clinicaltrials.gov) - Feb 28, 2018
P=N/A, N=0, Withheld, Sponsor: [Redacted]
- | Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
New trial, Head-to-Head: A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis (clinicaltrials.gov) - Feb 14, 2018
P=N/A, N=0, Withheld, Sponsor: [Redacted]
- | Tymlos (abaloparatide) / Radius, Teijin, Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal, HEOR: A Model for Assessing the Clinical and Economic Benefits of Bone-Forming Agents for Reducing Fractures in Postmenopausal Women at High, Near-Term Risk of Osteoporotic Fracture. (Pubmed Central) - Dec 27, 2017
Incorporating time-specific fracture effects in the Markov cohort model allowed for estimation of a range of cost savings, quality-adjusted life years gained, and clinical fractures avoided at different levels of fracture protection onset and magnitude. Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide.
- ||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed: A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis (clinicaltrials.gov) - Sep 6, 2017
P3, N=67, Active, not recruiting, Sponsor: Amgen
Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide. Recruiting --> Active, not recruiting
- ||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion: ARCH: Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - Jul 27, 2017
P3, N=4093, Completed, Sponsor: Amgen
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis (clinicaltrials.gov) - Feb 1, 2017
P3, N=60, Recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion: FRAME: Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - Jan 10, 2017
P3, N=7180, Completed, Sponsor: Amgen
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
New P3 trial: A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis (clinicaltrials.gov) - Jun 9, 2016
P3, N=60, Not yet recruiting, Sponsor: Amgen
- ||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion: BRIDGE: A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (clinicaltrials.gov) - May 16, 2016
P3, N=245, Completed, Sponsor: Amgen
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion: Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density (clinicaltrials.gov) - Mar 23, 2016
P2, N=419, Completed, Sponsor: Amgen
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial primary completion date: BRIDGE: A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (clinicaltrials.gov) - Mar 4, 2016
P3, N=245, Active, not recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Trial primary completion date: Jun 2016 --> Feb 2016
- |||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial primary completion date: FRAME: Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - Feb 23, 2016
P3, N=7180, Active, not recruiting, Sponsor: Amgen
Trial primary completion date: Jun 2016 --> Feb 2016 Trial primary completion date: Dec 2016 --> Dec 2015
- ||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion, Head-to-Head: A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - Jul 15, 2015
P3, N=294, Completed, Sponsor: Amgen
Trial primary completion date: Dec 2016 --> Dec 2015 Active, not recruiting --> Completed