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European Commission Approves Expanded Label for KAFTRIO® in Combination With Ivacaftor for People With Cystic Fibrosis

1. Vertex receives EU approval for KAFTRIO® label expansion to treat cystic fibrosis. 2. New approval increases potential patient base significantly for VRTX and enhances market reach.

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Why Very Bullish?

This approval could substantially increase sales for KAFTRIO®, similar to previous drug expansions that boosted revenue significantly.

How important is it?

The news directly impacts VRTX by allowing access to a larger patient population, which is crucial for long-term financial health.

Why Long Term?

The expanded indication for KAFTRIO® is likely to contribute to revenue growth for multiple years as more patients are treated.

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VRTX
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Commission has granted regulatory approval for a label expansion of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for the treatment of people with cystic fibrosis (CF). With this approval, the indication has been expanded to include all patients ages 2 years and older who have at least one non-class I mutation in the cystic fibrosis conductance regulator (CFTR).

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