Rapid US approval for next Vertex blockbuster

22 October 2019

Vertex Pharmaceuticals (Nasdaq: VRTX) has announced US Food and Drug Administration approval for Trikafta (elexacaftor/tezacaftor/ivacaftor/ivacaftor), for the treatment of cystic fibrosis (CF).

The approval covers people aged 12 years and older who have at least one F508del mutation, the most common CF-causing mutation.

Approval was granted a full five months ahead of schedule, the firm having benefited from a full range of regulatory boosts, with FDA Priority Review, Fast Track and Breakthrough Therapy designations.

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