Vertex says European Commission granted label extension for Orkambi
Vertex Pharmaceuticals announced that the European Commission has granted approval of the label extension for Orkambi for the treatment of children with cystic fibrosis aged two to five years old who have two copies of the F508del mutation, the most common form of the disease. "Today's approval by the European Commission brings us one step closer to our goal of bringing treatment to all people living with CF," said Reshma Kewalramani, MD, Executive Vice President, Global Medicines Development and Medical Affairs and Chief Medical Officer at Vertex. ''By treating the underlying cause of disease early, we can potentially modify its course and offer patients the chance of improved outcomes.'' Orkambi is already approved in the EU for the treatment of CF in patients aged 6 and older who have two copies of the F508del mutation.