Novartis - Heart Failure - Primary Endpoints, page-45

So we have:

1. Amgen, Cytokinetic's meeting their primary endpoint of reducing hospitalization but failing their secondary endpoint of mortality (only reduced by 8%). Missing the secondary endpoint on mortality was described as “underwhelming” and a “GALACTIC Disappointment,” JPMorgan analyst Cory Kasimov wrote, adding that missing the secondary endpoint “casts doubt on the outlook of this product candidate.”

As a result, Amgen's product is described as being dead in the water for failing to meet the more important secondary endpoint and a colossal failure given that "no reduction in the secondary endpoint of time of CV death was observed." They terminated their JV/partners, presumably on the basis of their reluctance to move forward with this drug, given its disappointing results....despite meeting its primary.

2. Novartis' failing their primary endpoint, but meeting their secondary endpoint. As a result, ODAC vote overwhelming in favour of approval + FDA approve, despite Entresto not meeting "its primary endpoint of reducing the rate of total heart failures and death....arguing the study's design may have produced misleading results."

3. FDA has provided previously its support for approving Biogen's aducanumab, despite its Phase 3 trial failure....

4. MSB missed the primary endpoint for reducing hospitalization rates, but showed overwhelming results in the secondary endpoint by reducing mortality. Maybe there was some misleading study design re hospitlization stats?

On the basis of Amgen and Novartis precedents, what does this mean for MSB and Rex-L - do we think FDA care more about hospitalization rates and primary endpoints, or mortality and overwhelming reductions in deaths? Think a way forward is starting to emerge....