Keeping Track: FDA Turns Down Telesta's MCNA, Broader Use Of Vertex' Kalydeco
The latest drug development news and highlights from our FDA Performance Tracker.
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Keeping track of US FDA approvals last week included watching the creative and the familiar.
Although a study testing a combo of the company's cystic fibrosis drug Kalydeco and the investigational VX-661 in patients with minimal CFTR function was ended due to futility, Vertex is on pace for a 2017 filing of the combo in three other CF subpopulations.
FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.