FDA accepts Amgen's BLA submission for PCSK9 inhibitor evolocumab – November 11, 2014

Yesterday, Amgen announced that the FDA has accepted the company's Biologics License Application (BLA) submission for its PCSK9 inhibitor evolocumab. intended for the treatment of hypercholesterolemia. The FDA has set a PDUFA date of August 27, 2015. This is the first product of its class to make it to the FDA, although Sanofi/Regeneron's alirocumab could leapfrog ahead with the help of a priority review voucher purchased to expedite the US regulatory process. In a recent twist, in late October Amgen filed a patent infringement lawsuit against Sanofi/Regeneron - the implications for alirocumab's timeline in the US remain unclear. As PCSK9 inhibitors have shown impressive potential in lowering LDL cholesterol (<50% from baseline in most trials) with a benign safety/tolerability profile, it is no surprise that the race to market remains fierce. Pfizer's bococizumab is next in line, having entered phase 3 late last year.