CF Therapy Kalydeco Receives Approval in the European Union
July 27, 2012
The European Commission has approved the use of the CF therapy Kalydeco™ for people with the G551D mutation ages 6 and older in the European Union.
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.