Unclear clinical relevance remains for Amgen’s (NASDAQ:AMGN) Phase III of its high LDL-C drug Repatha's (evolocumab) cardiovascular outcomes trial (CVOT), experts said, despite the company calling the study a success with a significant reduction in CV events.
Two experts noted the study achieved the primary endpoint, indicating reduced mortality and morbidity. But full trial read outs are still desired, they said, with one noting Repatha’s press release detailing its CVOT success fails to mention its hazard ratio or LDL-C reduction outcomes. However, two other experts added, its LDL-C lowering effects are fairly predictable based on other PCSK9 inhibitors’ LDL-C results. An analyst report notes the proportional relationship between LDL-C reduction and lowered CV risk supports clinically relevant data when FOURIER reads out in full.
One expert also noted the CVOT’s 15% powering for risk reduction may lack clinical relevance, whilst another expert argued payers may desire a minimum powering of 20% before loosening their current PCSK9 inhibitor prescription restrictions.