FDA Approves First Drug to Treat Smallpox; Recalls Valsartan Products

The Food and Drug Administration Friday approved the first drug intended to treat smallpox, which was eradicated in 1980 but could be used as a bioweapon. “This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” said FDA Commissioner Scott Gottlieb, M.D. Developed in conjunction with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, the drug was approved under the FDA’s Animal Rule, which allows efficacy findings from animal studies to support approval when it is not feasible or ethical to conduct efficacy trials in humans. Its safety was evaluated in 359 healthy human volunteers without a smallpox infection. In other news, FDA announced a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure, due to an impurity that could cause cancer. Patients taking the recalled products should contact their pharmacist or doctor to discuss treatment options, which may include a valsartan product not affected by the recall, the agency said.