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  • EMA recommends Symkevi and Kalydeco licence extensions

EMA committee recommends Symkevi and Kalydeco be licensed for younger age groups

The European Medicines Agency (EMA) human medicines committee (CHMP) has today recommended that the licences for life-saving drugs Symkevi and Kalydeco should be extended so that they can be prescribed to younger children with cystic fibrosis (CF).

Symkevi is currently available for use in the UK for people with CF aged 12 and over with two copies of F508del or one F508del and a residual function mutation. If approved, the new licence will mean that doctors can also prescribe Symkevi to children aged 6 to 11.

The EMA has also recommended that Kalydeco should be licensed for babies aged four to six months. Kalydeco has so far been available for eligible people with CF who are six months and over.

Dr Keith Brownlee, Director of Policy, Programmes & Support said: “Today’s recommendations to license Symkevi for children aged 6 to 11 and Kalydeco for babies aged four months to six months are a significant step forward in CF care, and pave the way for thousands of children to have access to a new disease-modifying treatment option.

“The next step is for the European Commission to formally issue the licences, which we expect to take around two months. After this, parents will be able to speak to their CF team for more details on their child’s eligibility and getting access to these drugs.”

There have been some momentous changes in the treatment of CF but there is still so much more that we need to do to ensure everyone gets access to life-changing treatment and support. If you are able, please consider making a donation today to ensure we can continue our work for everyone with cystic fibrosis.