Vertex nabs FDA approval for Alyftrek and Trikafta

US drugmaker Vertex Pharmaceuticals’ (Nasdaq: VRTX) shares were unmoved on Friday, despite receiving two new regulatory authorizations.

First, the US Food and Drug Administration (FDA) has approved the company’s Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people six years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to Alyftrek.

“Alyftrek is our fifth CFTR modulator to secure FDA approval and represents another significant milestone in our journey to serially innovate and to improve the lives of people living with cystic fibrosis,” said Dr Reshma Kewalramani, chief executive and president of Vertex. “Our north star for more than 20 years has been to address the underlying cause of cystic fibrosis, treat more people with this disease, and bring more people to normal levels of CFTR function — Alyftrek, with once-daily dosing, efficacy in 31 additional mutations, and lower sweat chloride levels than Trikafta, is another step in achieving this goal,” he added.