BioCentury
ARTICLE | Company News

Vertex gives update in CF

October 10, 2014 2:29 AM UTC

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) updated the progress of multiple programs as it prepared to present data at the North American Cystic Fibrosis Conference beginning today in Atlanta.

The company said it has submitted an sNDA of Kalydeco ivacaftor as monotherapy to treat cystic fibrosis (CF) patients aged six years and older with the R117H mutation in the CF transmembrane conductance regulator ( CFTR) gene. Vertex previously reported that Kalydeco only met the primary endpoint in the Phase III KONDUCT trial in patients at least 18 years old, although the trial enrolled patients six years and older. FDA's Pulmonary-Allergy Drugs Division will hold an advisory committee meeting on Oct. 21 to discuss the sNDA. ...