In its latest Phase III trial, Amgen said evolocumab (AMG 145) met its primary endpoint of significantly lowering LDL cholesterol in 49 patients with homozygous familial hypercholesterolemia, a rare ailment that lifts "bad" cholesterol levels to dangerous highs in adolescents. Evolocumab works by blocking the protein PCSK9 and thus helping the body clear LDL cholesterol from the blood, and Amgen said its latest study was the first to test out the pathway in patients with the disease, which affects about one in a million people.
The top-line success comes on the heels of 5 Phase III wins for evolocumab, and Amgen is working through a total of 14 studies on the drug with eyes on filing an FDA application this year. If everything goes according to plan, the California biotech will be the first PCSK9 player on the market, getting first crack at what could be a $10 billion market and beating out Regeneron ($REGN) and Sanofi's ($SNY) alirocumab and Pfizer's ($PFE) bococizumab (RN-316).
Read more: Amgen goes 6-for-6 in Phase III, leading the race for a new cardio blockbuster - FierceBiotech http://www.fiercebiotech.com/story/amgen-goes-6-6-phase-iii-leading-race-new-cardio-blockbuster/2014-03-17#ixzz2zUb3MJ00
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