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NATIONAL CF CHARITY WELCOMES US APPROVAL OF KALYDECO

01 Feb 12

The UK's leading charity supporting families, young people and adults with Cystic Fibrosis has welcomed US Food and Drug Administration approval of KALYDECO (Ivacaftor), from Vertex for use in people with CF ages 6 and older who have at least one copy of the G551D mutation. About 4 per cent of people with CF have this mutation and this first medicine to correct this genetic fault will significantly improve length and quality of life.

The Cystic Fibrosis Trust has learned that this will be available to people in the US from the end of the week. The charity now wants to ask the European Medicines Agency (EMA) to push the approval process in the EU through quicker, to allow this medicine to become available for patients with CF in the UK.

Matthew Reed, Chief Executive of the CF Trust said:
"The CF Trust is delighted that Kalydeco has been granted FDA approval. This is fantastic news for people living with CF and heralds a new era of drugs addressing the basic defect in CF. We now hope that the European Medicines Agency (EMA) will complete their own assessment as rapidly as possible so patients in the UK can have access to the same drugs as patients in the US. We will also be looking closely at the cost of providing this drug in the UK's CF Clinics."

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