The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 48 first-of-their-kind therapies in 2019, the second-highest number of new molecular entities cleared for the world’s largest pharmaceutical market in the past two decades.
The agency set the record in 2018, with 59 new molecular entities approved by the FDA’s Center for Drug Evaluation and Research, or CDER.
Many of the novel drugs cleared in 2019 are expected to change the trajectory of the diseases they were approved to treat, though a number of them come at a high cost.
Most of the 2019 approvals occurred under the oversight of acting FDA commissioners â€” first Ned Sharpless and later Brett Giroir â€” after Scott Gottlieb left the agency less than two years into the job.
Gottlieb’s replacement, Stephen Hahn, was sworn in as commissioner Dec. 17, 2019, just in time to oversee the last few approvals of the year.
Among the notable 2019 approvals by FDA’s CDER was Vertex Pharmaceuticals Inc.’s cystic fibrosis therapy Trikafta, Global Blood Therapeutics Inc.‘s sickle cell disease medicine Oxbryta, and Novartis AG’s Adakveo, a targeted therapy to reduce the frequency of vaso-occlusive crisis, a common and painful complication of sickle cell disease.
Story: 2019’s novel drugs aim to change disease trajectories, often at a high price
Chart of the week
Story: License to Pill: Biotech and pharma deals from Dec. 16-27
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