Vertex updates on US and EU Kalydeco filings; to get new CEO

US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) says that the US Food and Drug Administration has accepted the New Drug Application for its cystic fibrosis drug candidate Kalydeco (ivacaftor) and granted the company's request for six-month Priority Review.

Kalydeco targets the defective protein that causes cystic fibrosis in a subset of people with the disease. If approved, the drug will be the first treatment to target the underlying cause of CF. A target review date of April 18, 2012, is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.

European marketing application validated