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EMA recommends approval of Vertex's Orkambi to treat children with CF ages 6-11 with 2 copies of F508del mutation

Boston
Tuesday, November 14, 2017, 17:00 Hrs  [IST]

Vertex Pharmaceuticals Incorporated has announced that the European Union Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending extension of the Marketing Authorization for Orkambi (lumacafator/ivacaftor) to children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation. There are approximately 3,400 patients ages 6 through 11 eligible for this medicine in Europe.

"Cystic fibrosis is a systemic, multi-organ, progressive disease present from birth," said David Gillen, M.D., Head of International Medical Affairs at Vertex. "This recommendation brings us closer to being able to help more people with CF who currently do not have a medicine to treat the underlying cause of their disease."

Positive CHMP opinions are recommendations for approval to the European Commission, which has the authority to approve medicines for the European Union. The European Commission generally follows the recommendations of the CHMP and typically extends the Marketing Authorization within three months. In some countries, we have in place existing agreements that will make Orkambi available to this age group immediately following Marketing Authorization. In other countries, Vertex will begin the country-by-country reimbursement process following Marketing Authorization.

 

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