FDA advisory backs expanded use of Vertex’ CF drug

There was good news for US biotech firm Vertex Pharmaceuticals (Nasdaq: VRTX) yesterday, as a US Food and Drug Administration advisory committee 13 to two to recommend approval of Kalydeco (ivacaftor) in cystic fibrosis (CF) patients aged six and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene, which is the indication being reviewed by the FDA.

“Today’s recommendation is a positive and important step toward making ivacaftor available for people ages six and older with the R117H mutation,” said Jeffrey Chodakewitz, senior vice president and chief medical officer at Vertex, shares of which gained 3.2% to $108.16 in after-hours trading yesterday.

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