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Biobillionair

02/21/17 7:49 PM

#100891 RE: zumantu #100890

"The FDA" has approved APOC3 as a surrogate to test for CVD. CDER has put it in the pile with high trigs.

BB

http://www.prnewswire.com/news-releases/akcea-therapeutics-receives-orphan-drug-designation-from-the-us-fda-for-volanesorsen-isis-apociii-rx-for-the-treatment-of-familial-chylomicronemia-syndrome-300108774.html

Yet the agency tanked Vascepa development program and ANCHOR SPA. Guess the Agency didn't want to mess with Genzyme.
Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. Akcea Therapeutics™ is a trademark of Isis Pharmaceuticals, Inc. KYNAMRO® is a registered trademark of Genzyme Corporation.

Surely I'm overlooking the connections between the two programs......

https://www.ncbi.nlm.nih.gov/pubmed/25692924

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4556282/

FDA science:
https://www.fda.gov/forpatients/illness/cardiovascular/default.htm