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… Read more »
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