romosozumab (Evenity)
Jump to navigation
Jump to search
Indications
- osteoporosis (FDA-approved April 2019)
- lowers risk for vertebral fracture in postmenopausal women with osteoporosis*
- increases bone mineral density at the hip in bisphosphonate non-responders[3]
- conditionally recommended for women with very high risk of fracture[6]
- 1 year of use maximum, follow with bisphosphonate[6]
* industry-sponsored study[2][4]
* more effective than bisphosphonates in preventing clinical & vertebral fractures[7]
Dosage
- 70-210 mg SQ monthly
Adverse effects
- atypical femoral fracture
- osteonecrosis of the jaw[2]
- may increase cardiovascular risk (2.5 vs 1.9% for alendronate in women with history of fragility fracture)[4]
Mechanism of action
- binds to & inhibits sclerostin & increases bone formation & decreases bone resorption
More general terms
References
- ↑ McClung MR et al Romosozumab in Postmenopausal Women with Low Bone Mineral Density. N Engl J Med. Jan 1, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24382002 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1305224
Becker CB Sclerostin Inhibition for Osteoporosis - A New Approach. N Engl J Med. Jan 1, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24382003 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1315500 - ↑ 2.0 2.1 2.2 Cosman F, Crittenden DB, Adachi JD et al Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. September 18, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27641143 Free Article <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1607948
Rosen CJ Ingelfinger JR Building Better Bones with Biologics - A New Approach to Osteoporosis? N Engl J Med. September 18, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27641359 Free Article <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1611863 - ↑ 3.0 3.1 Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: A randomised, open-label, phase 3 trial. Lancet 2017 Jul 26; PMID: https://www.ncbi.nlm.nih.gov/pubmed/28755782
Compston J. Bone-forming agents in non-responders to bisphosphonates. Lancet 2017 Jul 26 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28755781 - ↑ 4.0 4.1 4.2 Saag KG, Petersen J, Brandi ML et al Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. September 11, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28892457 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1708322
- ↑ Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY <TM> (romosozumab). Potential New Treatment Option for the Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture. Amgen. Jan 16, 2019 https://www.prnewswire.com/news-releases/amgen-and-ucb-receive-positive-vote-from-fda-advisory-committee-in-favor-of-approval-for-evenity-romosozumab-300779812.html
FDA Advisory Committee. Briefing Information for the January 16, 2019 Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC). https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm629455.htm
FDA News Release. April 9, 2019 FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635653.htm - ↑ 6.0 6.1 6.2 Qaseem A, et al. Pharmacologic Treatment of Primary Osteoporosis or Low Bone Mass to Prevent Fractures in Adults: A Living Clinical Guideline From the American College of Physicians. Ann Intern Med. 2023. Jan 3; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36592456 https://www.acpjournals.org/doi/10.7326/M22-1034
- ↑ 7.0 7.1 Handel MN et al Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta- analysis, and meta-regression analysis of randomised clinical trials. BMJ. 2023. May 2;381:e068033 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37130601 PMCID: PMC10152340 Free PMC article https://www.bmj.com/content/381/bmj-2021-068033.short