Amgen’s Osteoporosis Drug Wins European Nod, With a Heart Warning
Summary
An osteoporosis drug developed by Amgen now has marketing approval in Europe, but it carries a warning that the medicine can raise the risk of cardiovascular problems. The antibody drug, given as a once monthly injection, was developed to block sclerostin, a protein involved in the signaling pathway that regulates bone growth. The delay allowed a rival osteoporosis drug from Waltham, MA-based Radius Health (NASDAQ: RDUS) to beat Amgen to the market. The Radius treatment provided an alternative to the Eli Lilly (NYSE: LLY) drug teriparatide (Forteo), which has been available to patients since 2002. The FDA’s approval of romosozumab requires its label to carry a warning that the drug may increase the risk of heart attack, stroke, and cardiovascular death.
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