Amgen, headquartered in Thousand Oaks, California, and UCB, based in Brussels, Belgium, resubmitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Evenity (romosozumab).
The FDA rejected the original BLA in July 2017, requesting more data related to adverse cardiovascular events. Evenity is a monoclonal antibody being developed to treat osteoporosis in postmenopausal women. When the companies announced topline data from the Phase III ARCH trial, which compared Evenity to Merck’s Fosamax (alendronate sodium) in May 2017, there was a higher risk of serious cardiovascular events with Evenity than Fosamax.
Evenity works by inhibiting the activity of sclerostin. This results in increased bone formation and reduced bone resorption.
The resubmission added data from two more pivotal Phase III trials, the ARCH trial, an alendronate-active comparator trial that included 4,093 postmenopausal women with osteoporosis who had a fracture, and the BRIDGE study, which included 245 men with osteoporosis. The original FDA submission had data from Phase I and II trials and the Phase III placebo-controlled FRAME trial, which included 7,180 postmenopausal women with osteoporosis.
“A fracture due to osteoporosis can be a life-altering event, and Evenity has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” said Sean Harper, Amgen’s executive vice president of Research and Development, in a statement. “We look forward to continuing our work with the FDA to demonstrate the benefit:risk profile for Evenity. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”
Fifty percent of women over the age of 50 in the U.S. will have a fracture related to osteoporosis, and as the population ages, that percentage is expected to be higher.
According to research firm GlobalData, if approved, Evenity is likely to become the leading branded product in the osteoporosis market by 2027, holding a 17 percent market share.
According to The Pharma Letter, “The osteoporosis market is likely to undergo significant changes over the next 10 years, growing at a compound annual growth rate (CAGR) of 4.3 percent, despite being dominated by generic bisphosphates, according to a recent report from data and analytics company. The value of the market sector is expected to reach $11.2 billion by 2027.”
Evenity was part of a collaboration deal signed in 2004 between Amgen and UCB to develop antibody therapeutics targeting sclerostin.
The therapeutic is currently being reviewed by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA).
“The burden of osteoporosis can have tremendous impact on a patient’s life,” said Pascale Richetta, UCB’s head of bone and executive vice president, in a statement. “We are one step closer in our ability to bring this first of its kind treatment to thousands of women affected by fragility fractures each year.”