Symkevi

tezacaftor / ivacaftor

Table of contents

Opinion

On 17 September 2020, 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 Symkevi. The marketing authorisation holder for this medicinal product is Vertex Pharmaceuticals (Ireland) Limited.

The CHMP recommended the approval of a new 50/75-mg strength for Symkevi tablets and an extension to the existing indication to allow use in children from 6 years of age. The full indication will now be as follows:1

Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 6 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3AG, S945L, S977F, R1070W, D1152H, 2789+5GA, 3272‑26AG, and 3849+10kbCT.

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.


1New text in bold, removed text as strikethrough

Key facts

Name
Symkevi
Agency product number
EMEA/H/C/004682
International non-proprietary name (INN) or common name
  • tezacaftor
  • ivacaftor
Active substance
  • tezacaftor
  • ivacaftor
Therapeutic area
Cystic Fibrosis
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
17/09/2020
Company name
Vertex Pharmaceuticals (Ireland) Limited
Status
Positive
Application type
Post-authorisation

How useful was this page?

Add your rating