Orkambi Efficacy Sways FDA Panel Despite Uncertainty Over Lumacaftor’s Role
This article was originally published in The Pink Sheet Daily
Executive Summary
Pulmonary-allergy drugs panel endorses approval of Vertex’s lumacaftor/ivacaftor fixed-dose combination for cystic fibrosis and suggests the question of whether the combination would be more or less effective than ivacaftor monotherapy is not relevant.