BioCentury
ARTICLE | Company News

Third CF candidate from Vertex approved

February 13, 2018 12:55 AM UTC

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said FDA approved Symdeko tezacaftor/ivacaftor to treat cystic fibrosis in patients ages 12 and older who have two copies of the delta F508 mutation or who have at least one CF gene mutation that is responsive to Symdeko. The company said it will begin shipping the product to U.S. pharmacies this week. Symdeko has an annual wholesale acquisition cost of $22,400 for a 28-day pack.

An MAA for Symdeko is under EMA review with a decision expected next half...