Kalydeco is the first drug to treat the underlying cause of CF -- a defective gene and its protein product, known as CFTR. Earlier this year, the U.S. Food and Drug Administration approved Kalydeco for people with the G551D mutation of CF in the United States.

In people with the G551D mutation, Kalydeco helps improve lung function and lower sweat chloride levels and helps patients gain weight - all key indicators that the drug is working.

The European Commission's decision comes only two months after the European Medicines Agency, which oversees drug approvals in the European Union, recommended the approval of Kalydeco.

Kalydeco was developed by Vertex with significant scientific, clinical and funding support from the Cystic Fibrosis Foundation.

Additional Resources

• Read the Vertex Pharmaceuticals press release.
• Read more about Kalydeco.
• Learn more about CF research.