MSD has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for sotatercept, marketed as Winrevair, to treat pulmonary arterial hypertension (PAH) in the adult population.
The therapy is used along with other PAH medications to improve exercise capacity in patients with moderate to severe limitations in physical activity.
Designed to address the underlying causes of PAH, which involves high blood pressure in the pulmonary arteries that can lead to right heart damage, sotatercept operates by easing the narrowing of these arteries, helping the heart pump blood more efficiently to the lungs and improving physical activity capabilities.
A pivotal study involving 323 PAH subjects demonstrated the therapy’s effectiveness compared to placebo in enhancing exercise capacity. The main measure of this was the change in the six-minute walk distance (6MWD) after 24 weeks of treatment.
Subjects who received the therapy, in addition to their standard PAH therapy, could walk approximately 34 metres farther than before treatment, while those on placebo improved by only one metre.
The median treatment difference between the therapy and placebo groups stood at 40.8 metres.
The UK regulator has recommended a dosing schedule of one injection every three weeks, which patients can self-administer.
Common adverse events reported in more than one in 10 subjects include low blood platelet count, elevated haemoglobin levels and skin rash.
The safety and effectiveness of the therapy will continue to be monitored closely by the agency. The approval of sotatercept came through the International Recognition Procedure (IRP).
MSD's acquisition of Acceleron Pharma in September 2021 for $11.5bn, at $180 per share, led to the addition of sotatercept to its portfolio.
MHRA healthcare quality and access interim executive director Julian Beach stated: “Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”
