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Questions & Answers

On 9 November 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Orkambi. The marketing authorisation holder for this medicinal product is Vertex Pharmaceuticals (Europe) Ltd.

The CHMP adopted an extension to the existing indication as follows1:

Orkambi is indicated for the treatment of cystic fibrosis (CF) in patients aged 126 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold, removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Orkambi (X-20) (English only) 2017-11-10  

Key facts

Product details for Orkambi
INN or common name

lumacaftor / ivacaftor

Therapeutic area Cystic Fibrosis
Active substance

lumacaftor / ivacaftor

Date opinion adopted09/11/2017
Company name

Vertex Pharmaceuticals (Europe) Ltd

Application typePost authorisation