Vertex, CF patients convince FDA panel to back Orkambi
This article was originally published in Scrip
Executive Summary
A US panel of pulmonary disease and other medical and statistical experts on 12 May gave a thumbs up to Vertex's Orkambi, a fixed-dose combination (FDC) of the company's FDA-approved cystic fibrosis medicine Kalydeco (ivacaftor) and new drug, lumacaftor, despite questions about whether the latter agent provides any added benefit.