FDA clears record number of drugs

January 15, 2019

FDA approved a record number of novel treatments in 2018.

FDA approved a record number of novel treatments in 2018.

FDA’s Center for Drug Evaluation and Research (CDER) cleared 59 novel drugs, compared to 33 annually on average from 2009 through 2017.

“The decisions we made on these approvals were generally completed by or before their goal dates as defined by Congressionally-approved agreements with industry,” wrote Janet Woodcock, MD, director of CDER, in a new report.

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Most of the drugs are approved in the US before any other country, Woodcock added.

Thirty-two percent of the novel drugs approved in 2018 were first-in-class-one indicator of the drug’s potential for strong positive impact on the health of the American people, according to the report.

First-in-class approvals included: erenumab-aooe (Aimovig, Amgen and Novartis) to treat migraines, cannabidiol (Epidiolex, GW Pharmaceuticals) to treat seizures in two rare and severe forms of epilepsy, and lofexidine hydrochloride (Lucemyra, US WorldMeds and Salix), the first non-opioid drug approved to help reduce opioid withdrawal symptoms.

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Plus, many novel drugs were approved for the first time in the US, including fremanezumab–vfrm (Ajovy, Teva) and galcanezumab-gnlm (Emgality, Eli Lilly and Co.) to prevent migraine.

Duvelisib (Copiktra, Verastem Oncology) was cleared to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Segesterone acetate and ethinyl estradiol (Annovera, Therapeutics MD), a combined hormonal contraceptive, is the first vaginal ring contraceptive that can be used for an entire year.

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