FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Other Notable Approvals

Endari (L-glutamine)

First drug approval for sickle cell disease in nearly 20 years. Indicated to reduce severe complications of sickle cell disease in adults and children aged 5 years or older.

Nucala (mepolizumab)

First approved therapy specifically for adults with eosinophilic granulomatosis with polyangiitis (EGPA), also known as Churg-Strauss syndrome.

Repatha (evolocumab)

First PCSK9 inhibitor approved to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.

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