Amgen's Repatha CVOT results are potential game-changer for lipid-lowering treatment

US biotech Amgen’s (Nasdaq: AMGN) Repatha (evolocumab) Phase III FOURIER trial will be deemed successful by experts if it shows a 35% reduction in major cardiovascular events (MACE), according to the latest Cardiology Report from BioPharm Insight (BPI).

“Amgen’s announcement at the start of February that it met its primary and key secondary composite endpoints was a hugely anticipated event for a drug predicted to have peak sales in excess of $7 billion,” said Peter Murphy, BPI senior editorial analyst. Amgen management has reiterated the cardiovascular outcomes trial (CVOT) trial is powered to show a 15% risk reduction but did not provide further details on FOURIER outcomes, which the market widely expects could be a game-changer for the lipid-lowering treatment space. While equity analysts think a 20% reduction has been hit, experts BPI spoke to said that anything lower than a 35% MACE reduction may mean that the cost outweighs the treatment benefit.

“Although Amgen’s news has significant implications for the entire PCSK9-inhibitor class, experts expect to see similar results between Repatha and its competitor Praluent,” said BPI reporter Alexandra Thompson. Amgen’s Repatha and Praluent (alirocumab), from Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals (Nasdaq: REGN), were approved within one month of each other in 2015 and are currently the only two anti-PCSK9s on the market.