Added Indication Won, At FDA -- Merck's Winrevair® (Sotatercept) -- For Treatment Of More Adults Living With Pulmonary Arterial Hypertension

This is a welcome FDA approved label expansion. [And it is an enhanced return on investment, from the Acceleron acquisition of about four years ago -- which had already proved out to be a wildly profitable M&A deal.]

It all means Merck will be added to formularies, on newer codes -- for added classes of COPD and PAH WHO Group 1 pulmonary hypertension patients, including critical cases. That's good news for the affected patients -- and for Rahway. Here's that bit, from Yahoo! News:

. . .[Merck] announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR^® (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.

WINREVAIR was initially approved based on the pivotal STELLAR study in March 2024.

Today’s approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death. . . .

Now you know -- a smallish power alley item to start our crisply sunny Fall Monday -- but keep a good thought for the people of Jamaica, now facing the wrath of. . . Melissa (Cat. 5). Yikes.

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