Merck MRK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the approval of its pulmonary arterial hypertension (PAH) drug Winrevair (sotatercept) in Europe. The CHMP recommended Winrevair in combination with other PAH therapies for treating adult patients with PAH (WHO Functional Class II to III) to improve exercise capacity.
The decision of the European Commission is expected in the third quarter of 2024. If approved by the European Commission, Winrevair will become the first activin signaling inhibitor therapy for PAH in Europe.
The approval of this novel activin signaling inhibitor was based on data from the STELLAR study. In the study, Winrevair plus background therapy significantly improved exercise capacity, increasing the six-minute walk distance by 41 meters from baseline at week 24, the study’s primary endpoint. Moreover, Winrevair demonstrated statistically significant improvements in eight out of nine secondary outcome measures, including a reduction in the risk of clinical worsening or death.
Winrevair (sotatercept) was approved for PAH in March 2024. Merck expects Winrevair to generate significant revenues over the long term.
Merck’s stock has risen 13.6% so far this year, underperforming an increase of 21.1% for the industry.
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PAH is a rare, progressive blood vessel disorder that affects the blood vessel walls in the lungs, resulting in elevated blood pressure. It exerts significant strain on the heart, as it works harder to pump blood through the lungs, eventually leading to heart failure if left untreated.
Winrevair is designed to target cellular signaling associated with vascular hyperproliferation and pathological remodeling to treat PAH. Winrevair works by blocking the proteins that contribute to the thickening of blood vessel walls in the lung.
Winrevair is the first novel activin signaling inhibitor approved by the FDA to treat PAH. Merck is also evaluating sotatercept in patients with more advanced disease in the phase III ZENITH and HYPERION studies.
Merck added Winrevair following its $11 billion acquisition of Acceleron Pharma in 2021.
Significant players in the PAH market are United Therapeutics UTHR and Johnson & Johnson JNJ. United Therapeutics markets four drugs to treat PAH in the United States — Remodulin, Orenitram, Tyvaso and Adcirca.
Remodulin is an injectable formulation of treprostinil. Orenitram is an oral version of treprostinil, while Tyvaso is an inhaled version of Treprostinil. Remodulin, Orenitram and Tyvaso recorded sales of $494.8 million, $359.4 million and $1.23 billion, respectively, in 2023.
As far as J&J is concerned, the PAH franchise was added to its portfolio with the 2017 acquisition of Actelion. J&J’s key PAH drugs are Opsumit and Uptravi. J&J recorded revenues of $3.8 billion from its PAH franchise in 2023, rising 11.6% year over year.
On Jun 28, the CHMP also recommended granting conditional marketing authorization for the expanded use of AbbVie’s ABBV lymphoma drug Tepkinly (epcoritamab) for treating relapsed or refractory follicular lymphoma (FL) after two or more therapies. Tepkinly, which is marketed as Epkinly in the United States, was approved by the FDA on an accelerated basis for the FL indication last week. The CHMP nod and the FDA’s approval were based on data from the FL cohort of the phase I/II EPCORE NHL study. Epkinly/Tepkinly was approved for relapsed-refractory third-line diffuse large B-cell lymphoma in 2023. AbbVie has developed Epkinly/Tepkinly in partnership with Genmab.
Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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