FDA ac­cepts pri­or­i­ty re­view for Re­gen­eron's evinacum­ab, which could join Pralu­ent in cho­les­terol mar­ket

Al­most a year ago to the day, Re­gen­eron an­nounced sol­id Phase III test­ing re­sults for evinacum­ab, a com­pound that’s de­signed to low­er LDL cho­les­terol in pa­tients who need treat­ment be­yond a PC­SK9 in­hibitor. As that an­niver­sary ap­proach­es, the biotech is po­ten­tial­ly one step clos­er to putting it on the mar­ket.

The FDA has grant­ed pri­or­i­ty re­view and ac­cept­ed a BLA for evinacum­ab as a sup­ple­ment to oth­er lipid-low­er­ing ther­a­pies in in­di­vid­u­als with ho­mozy­gous fa­mil­ial hy­per­c­ho­les­terolemia, Re­gen­eron an­nounced Wednes­day morn­ing. Re­gen­eron’s tar­get ac­tion date is next Feb­ru­ary 11.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER