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Ivacaftor and Lumacaftor combination
- Question
- Hello,
Could you tell me if this combination (Ivacaftor/Lumacaftor) has a marketing authorization and whether it is already prescribed by the CF Centers for delF508 mutations?
Thank you, - Answer
- Hello,
The answer is published in the last issue of Vaincre La Mucoviscidose December 2014 - February 2015 (No. 143, page 34), who gets the press release of the pharmaceutical company:
"Ivacaftor ASSOCIATED Lumacaftor: AUTHORIZATION REQUEST SUBMITTED TO THE EUROPEAN AGENCY
The laboratory Vertex Pharmaceuticals submitted early November an application for marketing authorization (MA) in the United States and Europe for the combination of ivacaftor (KalydecoTM) and Lumacaftor, intended for patients 12 years and older, homozygous for the F508del mutation.
This approach is based on the results of Phase 3 studies TRAFFIC and TRANSPORT made public in June and confirmed by the results of the 24-week extension study, presented at the Atlanta conference. All the data show moderate efficacy on lung function but statistically and clinically significant, with administration of the combination of these two molecules. »
Sincerely.
Gilles RAULT, MD, Roscoff CF Center
- 13.03.2015
