FDA panel backs Kalydeco in CF with R117H mutation
This article was originally published in Scrip
The FDA's Pulmonary-Allergy Drugs Advisory Committee in a 13-2 vote on 21 October supported the use of Vertex's Pharmaceuticals' Kalydeco (ivacaftor) in cystic fibrosis patients 6 years or older with the R117H mutation, despite failing a Phase III trial in that population.
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