Following the news that Merck reported positive top-line Phase III clinical trial results for its pulmonary arterial hypertension (PAH) pipeline drug, sotatercept;

Kaya Olczak, Healthcare Analyst at GlobalData, a leading data and analytics company, comments:

“Sotatercept has potential to fulfil a highly unmet need in the PAH space: the lack of a disease modifying therapy. Key opinion leaders (KOLs) interviewed by GlobalData expect sotatercept to become a leading therapy in the PAH market due to strong efficacy and clinical data, and as the first disease-modifying therapy—a significant breakthrough for PAH patients. However, the drug will face some hurdles in its initial launch.

“Notably, the initial five doses of sotatercept, administered subcutaneously every 21 days, requires specialty infrastructure that is often not available in community centers. KOLs also highlighted the possibility that users may not respond to the drug and issues with tolerance. Follow-up studies evaluating the long-term safety and efficacy of sotatercept are currently underway.

“Sotatercept is forecast to launch in 2024 in the US, and 2025 in the rest of the world. GlobalData predicts that sotatercept will gain a large market share and dominate other pipeline disease-modifying therapies such as imatinib.

“Originally developed by Acceleron Pharma, sotatercept is the only drug to have achieved breakthrough therapy designation in the US for PAH, alongside having achieved orphan designation in the US and the EU. Merck acquired Acceleron Pharma and its pipeline therapies in September 2021 for $11.5 billion—sotatercept being the key drug in Acceleron’s portfolio. KOLs interviewed by GlobalData believe that this acquisition has paid off for Merck, and has positioned it as a top competitor with potential to overtake the current leader in the PAH space, United Therapeutics.”