News

FDA Grants Priority Review to Vertex’s 1st Triple Combo for CF

The U.S. Food and Drug Administration (FDA) has granted priority review to Vertex’s new drug application for its triple combination — elexacaftor (VX-445) plus tezacaftor and Kalydeco (ivacaftor) — for cystic fibrosis (CF) patients who cannot use the company’s other disease-modifying treatments or don’t benefit as intended.

Citing Costs, Scotland Regulators Reject Adding Orkambi and Symkevi to National Health System

The Scottish Medicines Consortium (SMC) is recommending against bringing two of Vertex Pharmaceuticals’ approved cystic fibrosis (CF) treatments — Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor) — into routine use by adding them to the country’s national health system. Each treatment’s “cost in relation to its health…