A committee of the U.S. Food and Drug Administration gave its approval of a new drug from Amgen for the treatment of bone loss. The committee, however, recommended against approval of Prolia, also known as denosunab, to treat or prevent bone loss in women with breast cancer undergoing hormone ablation until additional data is available. It also recommended against approval of Prolia to prevent bone loss in low-risk patients in all three populations. Representatives of the Thousand Oaks-based biotech firm met Aug. 13 with the FDA’s Committee for Reproductive Health Drugs to review the potential use of Prolia. The committee made its recommendation after reviewing data from 30 clinical studies involving more than 12,000 patients. The panel recommended Prolia have a Risk Evaluation and Mitigation Strategy, which could include a medication guide and healthcare provider communications plan. The FDA often seeks the advice of an advisory committee when evaluating a potential new treatment but is not required to follow its recommendation. Amgen officials said the FDA is likely to make a decision in October about whether Prolia can go to market. Shares in Amgen closed down at $60.86. Eric Billingsley
