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Amgen (AMGN) and Union Chimique Belge send Romosozumab Biologics License Application to FDA

In a recent press release, Amgen (NASDAQ: AMGN) and Union Chimique Belge (UCB) disclosed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Romosozumab. Romosozumab is a monoclonal anti-sclerostin antibody for the treatment of osteoporosis in postmenopausal women, a group at increased risk of fracture. A BLA is similar to a New Drug Application (NDA). However, since Romosozumab is an antibody, it is classified as a biologic rather than a drug. Monoclonal antibodies are those made by identical immune cells that are all clones of a unique parent cell.

Announcing the application to regulators, Dr. Pascale Richetta, an executive vice president at UCB and head of its Bone Patient Value Unit, said:

“Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs. Many patients view fragility fractures as part of aging but these fractures are an indication of a weakened skeleton and a signal for intervention with medication. 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.”

Sclerostin is produced naturally in the body and acts mainly to inhibit bone formation, which is necessary to ensure that bones develop normally. However, to maintain the balance between bone formation and bone resorption, it may be necessary to inhibit the body’s production of sclerostin.

“Osteoporosis is a large public health problem yet is often overlooked, even in patients who have already experienced an osteoporotic fracture”, 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.”

Fractures due to bone fragility are widespread. In the U.S., about half of all women over the age of 50 will experience an osteoporotic fracture, yet just one-fifth of those injuries are treated in the first year.

The Biologics License Application for Romosozumab is based on data from the pivotal Phase 3 international, randomized, double-blind, placebo-controlled, parallel-group study in approximately 7,200 postmenopausal women with osteoporosis. UCB and Amgen will present results from the FRAME clinical trial at an upcoming medical congress.

For more information, visit www.amgen.com or www.ucb.com

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