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FDA approved 45 novel drugs in 2015, up from 41 in 2014 and the high for the past decade. From 2006 through 2015, FDA approved an average of 29 new pharmaceuticals each year. The agency says 14 of the new drugs approved were fast-tracked because they could address unmet medical needs. A group of 24 received priority reviews because they could potentially provide a significant advance in medical care. Targets for such treatment were reviewed within six months instead of the standard 10 months. Noteworthy approvals include Pfizer’s Ibrance to treat advanced metastatic breast cancer and Boehringer Ingelheim’s Praxbind to reverse adverse effects caused by the blood thinner dabigatran. About 47% of new drugs were approved to treat orphan diseases that affect 200,000 or fewer Americans. Among the approvals were Alexion’s Kanuma to treat lysosomal acid lipase deficiency, an inherited disorder that prevents the body from producing an enzyme for breaking down fats. Also approved was Orkambi, discovered by Vertex Pharmaceuticals, to treat cystic fibrosis.
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