Sunday, August 1, 2021

MHRA approves label extension for Vertex’s Kaftrio combo




The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a label extension for Vertex’s cystic fibrosis (CF) treatment Kaftrio in combination with ivacaftor.

Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is now available in Great Britain for the treatment of CF in all patients aged 12 years and older, who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

In April, the European Commission (EC) also approved this label extension for Vertex’s triple combination CF treatment.

This allowed eligible patients in the Republic of Ireland, Northern Ireland, Denmark and Luxembourg to gain access to the expanded indication for Kaftrio thank to long-term reimbursement agreements.

The label extension approval was supported by results of three Phase III studies in people aged 12 years and older with CF, which evaluated the treatment regimen in patients with a range of mutations.

Vertex utilized the EC decision reliance procedure in Great Britain – following this MHRA approval, the long-term reimbursement agreements that Vertex has in place in England, Scotland and Wales means that the patients who are now eligible for Kaftrio will get access ‘shortly’.



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