Date Set for Key Meeting on Vertex Drug
The FDA said it has set April 28 as the date of an advisory committee meeting on Cambridge, MA-based Vertex Pharmaceuticals’ (NASADAQ:VRTX) application for approval of its experimental hepatitis C drug telaprevir. The agency has a track record of often, but not always, following the recommendations of such advisory groups. Vertex is seeking approval of its drug for use in treating chronic hepatitis C genotype 1 infection in combination with two approved medicines for the disease in adult patients with “compensated liver disease who are previously untreated or who have failed previous therapy,” according to the FDA. Vertex has said that the likely date of the agency’s decision on the company’s application for approval of telaprevir is May 23.