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Pharmaceuticals / Submissions and Approvals

Regeneron’s Evinacumab Receives Breakthrough Therapy Designation by the FDA

April 12, 2017
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The FDA has awarded Regeneron breakthrough therapy designation for its hypercholesterolemia drug, evinacumab which is designed to lower cholesterol levels.

The drug is being developed to treat patients with homozygous familial hypercholesterolemia (HoFH).

The agency granted the designation based on positive interim Phase II results for evinacumab in HoFH patients.

Regeneron is planning to conduct a Phase III trial, but did not provide a timeline.

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