Speedy FDA review could soon bring real progress in PAH

29 September 2023

New Jersey, USA-based Merck & Co (NYSE: MRK) has been granted a Priority Review from the US regulator for its pulmonary arterial hypertension (PAH) candidate sotatercept.

The decision reflects the fact that there is a high level of unmet medical need for people with PAH, a rare, progressive and life-threatening blood vessel disorder for which there are no available disease-modifying therapies.

The update comes after Merck announced positive results for the candidate, in March, with data showing the therapy significantly improved exercise capacity, the study’s primary endpoint.

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