Vertex Pharmaceuticals announced that the European Commission has granted approval for the label expansion of KALYDECO for the treatment of infants down to 1 month of age with cystic fibrosis who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. As a result of existing access agreements in Austria, Czech Republic, Denmark, Ireland, Norway, Sweden, and The Netherlands, eligible patients will have access to the expanded indication of KALYDECO shortly following regulatory approval by the European Commission. Vertex will continue to work with reimbursement authorities across the European Union to ensure access for all other eligible patients. In the U.K., following MHRA approval at the end of 2023, and as a result of the existing reimbursement agreement between Vertex and the National Health Service, eligible infants ages 1 month and older in the U.K. have access to this expanded indication for KALYDECO.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on VRTX:
- Vertex Pharmaceuticals, TreeFrog Therapeutics announce licensing agreement
- CRISPR Therapeutics Stock (NASDAQ:CRSP) Pushes Lower, But Fundamentals Are Intact
- Vertex Pharmaceuticals announces advancements in suzetrigine pain program
- Novartis reports results from interim analysis of Phase 3 APPLAUSE-IgAN study
- Biotech Alert: Searches spiking for these stocks today