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Amgen Inc.

Partner : UCB

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Amgen And UCB Submit Biologics License Application For Romosozumab To The FDA

Based on Phase 3 FRAME Study in Postmenopausal Women With Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 21, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

"Osteoporosis is a large public health problem yet is often overlooked, even in patients who have already experienced an osteoporotic fracture,"1,2 said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This BLA submission is an exciting milestone; romosozumab has the potential to reduce the risk of fractures and help patients suffering from this serious disease."

The BLA for romosozumab is based on data from the pivotal Phase 3 placebo-controlled FRActure study in postemenopausal woMen with ostEoporosis (FRAME) in approximately 7,200 patients. Amgen and UCB plan to present results from the FRAME clinical trial at an upcoming medical congress.

"Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs.1,3,4 Many patients often view fragility fractures as part of aging,5 but these fractures are an indication of a weakened skeleton and a signal for intervention with medication," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We are pleased to submit the first regulatory submission for romosozumab and are committed to seeking global regulatory approvals in the hopes of making this important therapy available for appropriate patients at increased risk of fracture."

Osteoporosis-related fragility fractures are common.1,6 In the United States, one in two women over the age of 50 will experience an osteoporotic fracture.7 Data shows that only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post fracture.1
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Source: press release, 7/21/16. http://wwwext.amgen.com/media/news-releases/2016/07/amgen-and-ucb-submit...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Romosozumab (AMG-785) PMOEndocrine and MetabolismOsteoporosis post-menopausal (PMO)Sclerostin inhibitorSclerostin

Mechanism of action: Romosozumab (AMG-785) is a humanized monoclonal antibody that targets sclerostin, a protein secreted by bone cells that inhibits bone formation. AMG 785 (also known as CDP7851) is being developed in collaboration with UCB for bone-related conditions, including postmenopausal osteoporosis and fracture healing.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-09-15

Results: Pending