Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages 6 Months and 18 Years With the R117H Mutation in...
Vertex Pharmaceuticals Incorporated (VRTX)
Last vertex pharmaceuticals incorporated earnings: 4/29 04:01 pm
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Source: Business Wire
- If approved, KALYDECO® (ivacaftor) will be the first and only medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation, as young as 6 months of age - LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KALYDECO® (ivacaftor), to include the treatment of children and adolescents with cystic fibrosis (CF), ages 6 months and older weighing at least 5 kg who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.“Today’s announcement is important for young people with CF, as early intervention and treatment of this devastating and progressive disease is key to keeping patients healthier longer,” said Carmen Bozic, M.D., Executive Vice President and Chief Medical Office
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VRTX
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- 11/3/25 - Beat
VRTX
Sec Filings
- 12/5/25 - Form 4
- 12/5/25 - Form 4
- 12/5/25 - Form 4
- VRTX's page on the SEC website