Vertex Receives CHMP Positive Opinions For Orkambi, Kalydeco In The EU

(RTTNews) - Biotechnology company Vertex Pharmaceuticals Inc. (VRTX) announced that the European Union Committee for Medicinal Products for Human Use (CHMP) issued a positive Opinion recommending Marketing Authorization of Orkambi (lumacaftor/ivacaftor).

Orkambi is the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older with two copies of the F508del mutation. In Europe, approximately 12,000 people with CF ages 12 and older have two copies of this mutation.

The CHMP also issued a positive opinion recommending the indication of Kalydeco (ivacaftor) be expanded to include children ages 2 to 5 with CF. This in addition to the current approved use in people ages 6 and older, who have one of nine gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

These positive CHMP Opinions are recommendations for approval to the European Commission, which then has the authority to approve medicines for the European Union. The European Commission generally follows the recommendations of the CHMP and typically issues Marketing Authorization within three months.