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 The leading web portal for pharmacy resources, news, education and careers May 25, 2017
Pharmacy Choice - Pharmaceutical News - FDA Expands Approved Use Of Kalydeco To Treat Addl Mutations Of Cystic Fibrosis - May 25, 2017

Pharmacy News Article

 5/18/17 - FDA Expands Approved Use Of Kalydeco To Treat Addl Mutations Of Cystic Fibrosis

CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - The U.S. Food and Drug Administration today expanded the approved use of Kalydeco or ivacaftor for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. Kalydeco is manufactured for Boston-based Vertex Pharmaceuticals Inc (VRTX).

Cystic fibrosis affects the cells that produce mucus, sweat and digestive juices. These secreted fluids are normally thin and slippery due to the movement of sufficient ions (chloride) and water in and out of the cells. People with the progressive disease have a defective cystic fibrosis transmembrane conductance regulator (CFTR) gene that can't regulate the movement of ions and water, causing the secretions to become sticky and thick. The secretions build up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

Kalydeco, available as tablets or oral granules taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of cystic fibrosis, including weight gain. If the patient's genotype is unknown, an FDA-cleared cystic fibrosis mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Cystic fibrosis is a rare disease that affects about 30,000 people in the United States.Kalydeco is indicated for patients aged 2 and older who have one mutation in the CFTR gene that is responsive to drug treatment based on clinical and/or in vitro (laboratory) data. The expanded indication will affect another 3 percent of the cystic fibrosis population, impacting approximately 900 patients.



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