FDA Concerned About Denosumab Safety

Denosumab, with the provisional trade-name of Prolia, is under investigation by the FDA as an osteoperosis treatment. On August 13th, the FDA’s Advisory Committee for Reproductive Health Drugs will meet to consider whether denosumab should be recommended for approval. However, the FDA has recently expressed some concerns about denosumab. Those include concerns that the drug could increase serious infections, delay fracture healing, and possibly promote tumor development and progression. Denosumab is manufactured by Amgen, which applied for FDA approval last December for the drug to prevent and treat osteoperosis. The New England Journal of Medicine recently published two of the denosumab registration trials, which demonstrated that denosumab is as effective as biphosphonate drugs in treating osteoperosis. Denosumab also has a convenient dosing regimen of a subcutaneous injection every six months, which may be favorable due to the poor compliance with daily oral osteoperosis medicines. Despite these factors, the risk profile for denosumab is still a big concern for the FDA.