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MRK Gets Positive CHMP Opinion for Expanded Use of Winrevair in PAH
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Key Takeaways
MRK gets positive CHMP opinion for expanded Winrevair use in adult PAH patients with WHO FC II, III and IV.
The recommendation is based on phase III ZENITH data showing a 76% reduction in morbidity and mortality risk.
The opinion will be reviewed by the European Commission, with a final decision expected in Q1 2026.
Merck (MRK - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending approval of an expanded indication for its pulmonary arterial hypertension (PAH) drug, Winrevair (sotatercept).
The CHMP has now recommended the approval of an expanded indication for Winrevair in combination with other PAH therapies, for the treatment of PAH in adult patients with WHO Functional Class (“FC”) II, III and IV, based on data from the phase III ZENITH study.
The CHMP’s opinion will now be reviewed by the European Commission and a final decision is expected in the first quarter of 2026.
Winrevair is currently approved in the European Union for treating adults with PAH with WHO FC II to III, to improve exercise capacity.
MRK’s Price Performance
Year to date, shares of Merck have risen 0.9% compared with the industry’s rally of 15.9%.
Image Source: Zacks Investment Research
More on the Latest CHMP Opinion for MRK's Winrevair
The CHMP recommendation for expanded indication for Winrevair was based on data from the phase III ZENITH study.
Data from the same showed that Winrevair, when added to background therapy, led to a statistically significant and clinically meaningful 76% reduction in the risk of major morbidity and mortality outcomes, in adults with PAH WHO functional class III or IV versus placebo – the study’s primary endpoint.
While making this recommendation, the CHMP also reviewed morbidity and mortality outcomes data from a secondary endpoint of the pivotal phase III STELLAR study.
If approved, the broader indication would reflect Winrevair’s effect on morbidity and mortality in adults with PAH, expanding its overall use to include WHO functional class II, III and IV patients, beyond just improving exercise capacity.
MRK's Recent Developments With Winrevair
Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March 2024 based on data from the STELLAR study.
The FDA recently approved an update to the Winrevair product label in the United States based on data from the ZENITH study, which evaluated the drug in patients with PAH, WHO Group 1 FC III or IV at high risk of mortality.
Following the FDA nod for this expanded indication, Winrevair became the first PAH therapy to have an indication that includes components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.
Last month, Merck announced that the phase II CADENCE study, which evaluated Winrevair for treating adults with combined post and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF), met its primary endpoint.
Data from the CADENCE study showed that treatment with Winrevair led to a statistically significant and clinically meaningful reduction in pulmonary vascular resistance from baseline at 24 weeks versus placebo.
Winrevair recorded sales worth $976 million in the first nine months of 2025.
Winrevair is one of Merck’s newest products, which it is counting on to boost the long-term growth. However, Winrevair is likely to face stiff competition in the PAH market.
Significant players in the PAH market are United Therapeutics (UTHR - Free Report) and Johnson & Johnson (JNJ - Free Report) .
United Therapeutics markets four drugs to treat PAH in the United States — Remodulin, Orenitram, Tyvaso and Adcirca. UTHR’s Tyvaso recorded sales of $1.41 billion, while Remodulin and Orenitram generated sales of $398.8 million and $375.7 million, respectively, in the first nine months of 2025.
J&J’s key PAH drugs include Opsumit and Uptravi. JNJ recorded revenues of $3.25 billion from its PAH franchise in the first nine months of 2025.
Image: Bigstock
MRK Gets Positive CHMP Opinion for Expanded Use of Winrevair in PAH
Key Takeaways
Merck (MRK - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending approval of an expanded indication for its pulmonary arterial hypertension (PAH) drug, Winrevair (sotatercept).
The CHMP has now recommended the approval of an expanded indication for Winrevair in combination with other PAH therapies, for the treatment of PAH in adult patients with WHO Functional Class (“FC”) II, III and IV, based on data from the phase III ZENITH study.
The CHMP’s opinion will now be reviewed by the European Commission and a final decision is expected in the first quarter of 2026.
Winrevair is currently approved in the European Union for treating adults with PAH with WHO FC II to III, to improve exercise capacity.
MRK’s Price Performance
Year to date, shares of Merck have risen 0.9% compared with the industry’s rally of 15.9%.
Image Source: Zacks Investment Research
More on the Latest CHMP Opinion for MRK's Winrevair
The CHMP recommendation for expanded indication for Winrevair was based on data from the phase III ZENITH study.
Data from the same showed that Winrevair, when added to background therapy, led to a statistically significant and clinically meaningful 76% reduction in the risk of major morbidity and mortality outcomes, in adults with PAH WHO functional class III or IV versus placebo – the study’s primary endpoint.
While making this recommendation, the CHMP also reviewed morbidity and mortality outcomes data from a secondary endpoint of the pivotal phase III STELLAR study.
If approved, the broader indication would reflect Winrevair’s effect on morbidity and mortality in adults with PAH, expanding its overall use to include WHO functional class II, III and IV patients, beyond just improving exercise capacity.
MRK's Recent Developments With Winrevair
Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March 2024 based on data from the STELLAR study.
The FDA recently approved an update to the Winrevair product label in the United States based on data from the ZENITH study, which evaluated the drug in patients with PAH, WHO Group 1 FC III or IV at high risk of mortality.
Following the FDA nod for this expanded indication, Winrevair became the first PAH therapy to have an indication that includes components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.
Last month, Merck announced that the phase II CADENCE study, which evaluated Winrevair for treating adults with combined post and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF), met its primary endpoint.
Data from the CADENCE study showed that treatment with Winrevair led to a statistically significant and clinically meaningful reduction in pulmonary vascular resistance from baseline at 24 weeks versus placebo.
Winrevair recorded sales worth $976 million in the first nine months of 2025.
Winrevair is one of Merck’s newest products, which it is counting on to boost the long-term growth. However, Winrevair is likely to face stiff competition in the PAH market.
Significant players in the PAH market are United Therapeutics (UTHR - Free Report) and Johnson & Johnson (JNJ - Free Report) .
United Therapeutics markets four drugs to treat PAH in the United States — Remodulin, Orenitram, Tyvaso and Adcirca. UTHR’s Tyvaso recorded sales of $1.41 billion, while Remodulin and Orenitram generated sales of $398.8 million and $375.7 million, respectively, in the first nine months of 2025.
J&J’s key PAH drugs include Opsumit and Uptravi. JNJ recorded revenues of $3.25 billion from its PAH franchise in the first nine months of 2025.
MRK's Zacks Rank
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.