FDA and EMA accept Vertex applications for cystic fibrosis combo drug

US biotech firm Vertex Pharmaceuticals (Nasdaq: VRTX) saw its shares rise 1.85% to $156.08 after the company updated on regulatory filings for the combination cystic fibrosis drug candidate.

Vertex announced the acceptance of its applications for the use of the tezacaftor/ivacaftor (marketed as Kalydeco) combination treatment in people with cystic fibrosis (CF) aged 12 and older who have two copies of the F508del mutation or one F508del mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor by the US Food and Drug Administration and the European Medicines Agency.

In the USA, the FDA has granted Priority Review of the New Drug Application and set an action date of February 28, 2018. The submissions are supported by positive results from two global Phase III studies.