FDA Approves ORKAMBI® (lumacaftor/ivacaftor) as First Medicine to Treat the Underlying Cause of Cystic Fibrosis for Children Ages 2-5 Years 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
- Approximately 1,300 people in the U.S. ages 2 through 5 years have two copies of the F508del mutation, the most common genetic form of the disease - BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved ORKAMBI® (lumacaftor/ivacaftor) to include use in children ages 2 through 5 years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population. ORKAMBI oral granules are available in two dosage strengths (lumacaftor 100mg/ivacaftor 125mg and lumacaftor 150mg/ivacaftor 188mg) for weight-based dosing. ORKAMBI oral granules should be available for fulfillment within 2 to 4 weeks. “For the first time, children ages 2 through 5 who have the most common form of CF have a treatment for the underly
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