Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
Vertex Pharmaceuticals Incorporated (VRTX)
Last vertex pharmaceuticals incorporated earnings: 4/29 04:01 pm
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Source: Business Wire
- If approved, lumacaftor/ivacaftor will be the first medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 young children with two copies of the F508del mutation - LONDON--(BUSINESS WIRE)-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ORKAMBI® (lumacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, lumacaftor/ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF for patients aged 2 to 5 years old who have two copies of the F508del mutatio
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