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Approval Alert: FDA Approves Regeneron’s Praluent® (alirocumab) Injection for Treating Children with Genetic Form of High Cholesterol

Mar 11, 2024

On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024.  The approval was based on Phase 3 randomized trials in patients aged 8-17.  The results, published in the Journal of the American Medical Association Pediatrics, show that those who received alirocumab every four weeks had 31% lower LDL-C than the placebo group at 24 weeks.

In 2014, Amgen commenced litigation against Sanofi, alleging that Sanofi’s and Regeneron’s Praluent® infringed genus claims of Amgen’s patents relating to Repatha® (evolocumab).  In May 2023, the US Supreme Court published its decision affirming a ruling of the Federal Circuit Court that Amgen’s genus claims were invalid for lack of enablement.