FDA Recommends Second New Hepatitis C Drug for Approval
In the last week, a Food and Drug Administration committee has unanimously recommended two new hepatitis C drugs for approval. Telaprevir, a protease inhibitor manufactured by Vertex Pharmaceuticals, prevents the hepatitis C virus from replicating. A similar protease inhibitor manufactured by Merck & Co., boceprevir, was recommended on Wednesday.
According to Vertex, about 79% of study patients who hadn’t been treated and 85% of those who were treated but relapsed showed significant improvement when treated with telaprevir. The drug is administered orally 3 times a day with food. Both drugs are designed to be used in conjunction with the current standard care of ribavirin and peginterferon. Studies show that taking all three drugs is more beneficial to patients than taking only two.
Side effects of the two drugs include rash and anemia. Members of the panel expressed concern, but concluded that the benefits of the drugs outweigh the risks. The FDA will now consider whether to approve one or both the drugs.