Thursday, January 30, 2025

Merck Stops PAH Clinical Trial Early, To Give All Participants Winrevair™ -- Efficacy Well Established; Ethical Protocols Invoked.


The HYPERION Phase III clincial trial has now been stopped early, citing efficacy data in two other Merck PAH trials. This is very good news for people suffering with PAH. And it is the moral imperative -- making sure no patient is getting a placebo.

In passing, I'd also mention that Merck has made an FDA approvable filing, and is about mid-course, on a separate Welireg™ clinical trial, assessing yet another adrenal gland oncological application -- and that one looks very promising as well.

Here's the latest, on the HYPERION study stoppage:

. . .[Merck will] stop a late-stage study testing its drug to treat pulmonary arterial hypertension (PAH) ahead of time based on strong efficacy shown in previous studies, the drugmaker said on Thursday.

The therapy, branded Winrevair™, is already approved for treating the rare condition which causes high blood pressure in the lungs, leading to symptoms such as shortness of breath, chest pain and dizziness. . . .

Analysts expect Winrevair to become a multi-billion-dollar product for Merck. . . . Merck's decision was partly based on interim data from another late-stage study, named ZENITH, in which Winrevair helped significantly reduce the risk of death in PAH patients. . . .


Onward, keeping those families who had loved ones among the 67 onboard the two crafts last night into Reagan, in our meditations. The last US airline disaster was in 2009 -- so a remarkable safety record for the industry overall. . . but none of that matters to these families, now. Just. . . awful.

नमस्ते

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