Alirocumab: Regulatory History

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May 25, 2026latest review

Alirocumab: Regulatory History library

Showing 2 of 2 clinical reviews.

QuestionsMay 25, 2026

How Long Has Praluent Been on the Market?

Praluent (alirocumab) was FDA approved July 24, 2015, and has been on the market over 9 years, with a cardiovascular indication added in April 2019.

Clinical ReviewsMay 25, 2026

Praluent (Alirocumab) Global Regulatory Status: FDA Approval, EMA Authorization, and Label Updates

Regulatory overview of Praluent (alirocumab): FDA approval history, EMA authorization, the ODYSSEY OUTCOMES cardiovascular indication, label changes, and what remains unverified in secondary summaries of this history.