ARTICLE | Company News

Vertex gets breakthrough for VX-661/Kalydeco combo

January 30, 2014 2:18 AM UTC

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) reported 4Q13 and 2013 financial results late Wednesday and disclosed that FDA granted breakthrough therapy designation for VX-661 in combination with cystic fibrosis (CF) drug Kalydeco ivacaftor to treat CF in patients with two copies of the delta F508 CF transmembrane conductance regulator ( CFTR) mutation. This half, the company plans to start a Phase II trial to evaluate the combination in this population. VX-661 is a small molecule CFTR corrector, and Kalydeco is a small molecule potentiator of CFTR. Kalydeco already has breakthrough therapy designation as monotherapy and in combination with lumacaftor ( VX-809), also a small molecule CFTR corrector. ...