Vertex (VRTX) Orkambi sNDA Accepted with Priority Review
Vertex Pharmaceuticals Incorporated VRTX announced that the FDA has accepted its supplemental New Drug Application (sNDA) and granted Priority Review for its cystic fibrosis (CF) drug, Orkambi, for the treatment of CF in patients aged 6 to 11 years who have two copies of the F508del mutation. Orkambi is a combination of lumacaftor and Kalydeco (ivacaftor), a marketed CF drug in the company’s portfolio. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of Sep 30, 2016. […]