Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY™ (romosozumab)
"We are pleased with the Committee's recommendation to approve EVENITY for the treatment of postmenopausal women with osteoporosis at high risk for fracture," said
The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients.2 Notable Phase 3 studies include FRAME,3 a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH,4 an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; and STRUCTURE,5 an active comparator-controlled study with 436 postmenopausal women with osteoporosis. The BRUDAC evaluated the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, including the cardiovascular safety finding seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.
"Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis. This is why new treatment options, like EVENITY, are so important," said Dr.
In the U.S., one in two women over the age of 50 will experience an osteoporotic fracture.6 Unfortunately, only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post-fracture.7
EVENITY was granted marketing authorization – its first approval anywhere in the world – by the
About EVENITY™* (romosozumab)
EVENITY is an investigational bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing EVENITY to either placebo or active comparator in more than 11,000 postmenopausal women with osteoporosis.
About the Pivotal EVENITY Clinical Trials
FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis at risk for fracture. The study evaluated the effectiveness of EVENITY treatment (210 mg administered monthly), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months.
ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) is a randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment (210 mg administered monthly) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to assess its effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.
About the STRUCTURE Clinical Trial
STRUCTURE (Study evaluating effect of romosozumab compared with teriparatide in postmenopausal women with osteoporosis at high risk for fracture previously treated with bisphosphonate therapy) is a Phase 3, multi-center, international, randomized, open-label, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in women with postmenopausal osteoporosis. The trial included 436 postmenopausal women averaging 72 years of age who had postmenopausal osteoporosis and a history of bone fracture; patients were treated with bisphosphonate therapy for a minimum of three years prior to screening, with treatment with alendronate (70 mg weekly or equivalent) during the year immediately prior to screening.
About Fragility Fractures
Worldwide, one in three women and one in five men, over the age of 50, will suffer a fragility fracture due to osteoporosis and with an aging population these numbers will rise.9 Yet despite this, there is a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture.7 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed and actual results may differ materially from those
The scientific information discussed in this news release related to
UCB Forward-Looking Statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
*The trade name EVENITY™ is provisionally approved for use by the
CONTACT: UCB, Brussels
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Isabelle Ghellynck, Investor Relations, UCB
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.
- FDA Briefing Document. Meeting of the Bone,
Reproductive and Urologic Drugs Advisory Committee. January 16, 2019. BLA 761062 Romosozumab Amgen, Inc.Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM629456.pdf. Accessed January 14, 2019.
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. Accessed January 14, 2019.
- Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH). Available at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1. Accessed January 14, 2019.
- An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE). Available at: https://clinicaltrials.gov/ct2/show/NCT01796301?term=STRUCTURE+ROMOSOZUMAB&rank=1. Accessed January 14, 2019.
National Osteoporosis Foundation. Osteoporosis Fast Facts. https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed January 14, 2019. International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics. Accessed January 14, 2019.
- Amgen Astellas BioPharma (2018) Evenity subcutaneous injection 105mg syringe: 2 syringes. [package insert]
Tokyo, Japan. International Osteoporosis Foundation. Patient Brochure. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf. Accessed January 14, 2019.
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