Vertex’s cystic fibrosis treatment wins EU regulator’s backing
Vertex Pharmaceuticals Inc.’s Kalydeco, the first medicine to attack the underlying cause of cystic fibrosis, won the backing of the European Union’s drug regulator.
Kalydeco should be approved by the European Commission for use against a rare form of cystic fibrosis in patients ages 6 and older who have a specific gene mutation, the London-based European Medicines Agency said today in a statement.
Vertex is based in Cambridge.
In January, the US Food and Drug Administration approved Kalydeco.
Earlier this month, shares of Vertex surged more than 55 percent after the company released interim data showing an experimental drug combination dramatically improved breathing for some cystic fibrosis patients taking it in a clinical trial.
About a year ago, a Vertex drug called Incivek won FDA approval to combat the hepatitis C virus.
Vertex plans to move its headquarters to the South Boston Waterfront late in 2013. The company has more than 2,000 employees worldwide, including 1,500 in Massachusetts.