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The US FDA grants breakthrough therapy status to Regeneron Pharmaceuticals's evinacumab.

M2 EQUITYBITES-April 10, 2017-The US FDA grants breakthrough therapy status to Regeneron Pharmaceuticals's evinacumab

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The US Food and Drug Administration (FDA) has granted breakthrough therapy status to United States-based Regeneron Pharmaceuticals (NASDAQ: REGN)'s evinacumab, intended to treat patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder, which can result in premature cardiovascular disease due to high levels of LDL cholesterol, it was reported on Friday.

The product is an investigational monoclonal antibody to angiopoietin-like protein 3 (ANGPTL3).

Presently, the firm is planning a phase three trial after positive interim phase two results for evinacumab in May 2016. Regeneron fixed the primary endpoint of the trial as the mean percent change in LDL-C levels from baseline to week four. The company's proof-of-concept study had demonstrated that the product, added to current lipid-lowering therapy, reduced low-density lipoprotein cholesterol levels by an additional 55% at week four compared with baseline, according to the company.

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Publication:M2 EquityBites (EQB)
Date:Apr 10, 2017
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