CHMP Endorsement Boosts Momentum for Merck & Co.'s Winrevair

Three months after receiving approval from the U.S. Food and Drug Administration (FDA), Merck & Co.’s pulmonary arterial hypertension (PAH) treatment, Winrevair (sotatercept), has moved closer to gaining approval in Europe. This advancement comes after the drug advisory body for the European Union adopted a favorable opinion on the company's marketing application this past Friday.

Winrevair is notable for being the first therapy that works by inhibiting activin signaling specifically for PAH. It is recommended to be used alongside other PAH treatments for adult patients classified under WHO Functional Class II to III. This classification indicates patients who experience limitations in physical activity but are comfortable at rest. The primary benefit of Winrevair is its ability to enhance exercise capacity in these patients.

The positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) is based on the findings from the Phase III STELLAR trial. This pivotal study demonstrated that incorporating Winrevair into the existing treatment regimen significantly boosted exercise capacity. This improvement was quantified using the six-minute walk distance (6MWD) test, a standard measure of exercise ability in PAH patients. The results were promising, with patients receiving Winrevair walking an average of 40.8 meters farther at 24 weeks compared to those who received a placebo.

Beyond improving exercise capacity, Winrevair also showed an impressive reduction in the risk of death or clinical worsening events related to PAH by 84%. This secondary outcome is a crucial differentiating factor from current PAH therapies on the market, highlighting Winrevair's potential to significantly enhance patient outcomes.

As the European Commission typically aligns with CHMP's opinions, this recommendation brings Winrevair one step closer to becoming an available treatment option for PAH patients in Europe. The adoption of Winrevair could represent a significant advancement in the management of PAH, offering new hope to patients who struggle with the limitations imposed by this condition. Further updates are anticipated as the approval process progresses.