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With New Data, Amgen Tries Again for FDA OK of Osteoporosis Drug

Xconomy San Francisco — 

More than a year after the FDA rejected Amgen’s experimental osteoporosis drug due to safety concerns, the Thousand Oaks, CA, company has teed up a new application.

The Amgen (NASDAQ: AMGN) drug, romosozumab (Evenity), is an antibody treatment meant to strengthen bones and reduce the chance that they could break. But while romosozumab did lower the risk of fractures in Phase 3 testing last year, it also led to more cardiovascular side effects. The FDA rejected Amgen’s drug as a result.

Amgen and Belgian partner UCB are trying again, however. They’ve filed a new approval application hoping that additional data from two more recent late-stage studies—one trial in postmenopausal women with osteoporosis, the other in men—can ease the FDA’s concerns. The companies say the additional information from these studies will allow the FDA to evaluate the safety of the drug, including the heart risks that emerged last year.

Amgen is trying to catch up to Waltham, MA-based Radius Health (NASDAQ: RDUS), whose osteoporosis drug, abaloparatide (Tymlos), was approved by the FDA last year. Radius reported $12 million in 2017 sales of the drug. Both companies are angling to take market share from teriparatide (Forteo), the Eli Lilly (NYSE: LLY) osteoporosis drug that accounted for more than $1.7 billion in 2017 sales worldwide.

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