FDA committee OKs Amgen’s Evenity
A U.S. Food and Drug Administration advisory committee voted in favor of a new approval for Amgen’s osteoporosis treatment Evenity for use by postmenopausal women.
The Bone, Reproductive and Urologic Drugs Advisory Committee voted to approve the expanded use of the treatment following the release of new safety and efficacy data and emphasized the need for further review post-marketing, the Thousand Oaks biotech giant said in a news release Jan. 16.
“A fracture due to osteoporosis can be devastating to the lives of patients. After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated,” said Amgen’s head of research and development David Reese. “Despite available therapies, these women who are at high risk for fracture could benefit from an additional treatment option that has the potential to both build new bone and slow existing bone loss.”
The advisory committee’s decision is not binding for the regulatory agency, but the FDA takes its advice into consideration when making its decision.
Developed in partnership with biopharma multinational UCB, Evenity received approval from the Japanese Ministry of Health, Labor and Welfare Jan. 8 to treat osteoporosis patients at a high risk of fracture and is currently in review by European regulators. Shares for Amgen rose 1.5 percent Jan. 16, more than $3, ending at $201.92.
Around 14,000 patients have been enrolled in studies for Evenity, the company said, including postmenopausal women with osteoporosis at risk for a fracture or who have a prior history of fracture. Studies have evaluated its cardiovascular safety and potential to increase bone mineral density.
“Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis,” said Pascale Richetta, head of bone and executive vice president at UCB. “The committee’s recommendation represents a step forward for patients and we look forward to working with our partner, Amgen, in the coming months to bring Evenity to the patients that need it most.”
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