Vertex gains EU label extension for Kalydeco
Days after revealing positive Phase III data for its latest cystic fibrosis candidate, Vertex Pharmaceuticals (Nasdaq: VRTX) gave investors more good news on Thursday, in the form of a new European approval for Kalydeco (ivacaftor).
The East Coast, USA-based drugmaker has been granted a label extension to include the treatment of people with cystic fibrosis (CF) aged 1-2 years who have certain genetic mutations. It is currently approved for those two and over.
Chief medical officer Reshma Kewalramani said: “For the first time, EU physicians can now treat the underlying cause of CF earlier than ever, helping to improve clinical outcomes in children as young as 12 months.”
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