Added use for Vertex' Symkevi with Kalydeco approved by EC

US biotech firm Vertex Pharmaceuticals (Nasdaq: VRTX) on Friday announced that the European Commission has granted approval of the label extension for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor), sending its shares up 3.9% by close of trading and a further 1.4% to $223.60 after hours

The new label will include the treatment of cystic fibrosis (CF) in patients aged six years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.

“With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Dr Reshma Kewalramani, chief executive and president at Vertex. “Today’s approval brings us closer to our ultimate goal of providing medicines for all people with CF.”