The Medicines and Healthcare products Regulatory Agency (MHRA) has approved (27 December 2024) the medicine sotatercept (Winrevair) to treat pulmonary arterial hypertension (PAH).
Sotatercept is used, in combination with other medicines to treat PAH, in adults with moderate or marked limitations of physical activity, to improve exercise capacity.
Patients with pulmonary arterial hypertension have high blood pressure in the blood vessels that supply the lungs (pulmonary arteries). It's a rare and serious condition that can damage the right side of the heart.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
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.
The recommended dosing schedule is one injection every three weeks, via self-administration. The patient's doctor will tell the patient how much of the medicine to take and when to take it. It is very important that the patient follows the instructions from their doctor.
The active ingredient, sotatercept, acts on the causes of PAH responsible for the narrowing of the arteries in the lungs. This makes it easier for the heart to pump blood to the lungs, improving the ability to be physically active.
A main study was conducted, involving 323 patients with PAH. The study showed that sotatercept was more effective than placebo at improving the ability of adults with PAH to exercise. The main measure of effectiveness was the difference in the distance patients could walk in 6 minutes before and after treatment.
After 24 weeks of treatment, sotatercept given in addition to other PAH medicines improved the distance patients could walk in 6 minutes by around 34 metres, compared with 1 metre in patients who received placebo instead. The median (average) treatment difference between the sotatercept and placebo groups was 40.8 metres.
The most common side effects of the medicine (which may affect more than 1 in 10 people) are low number of blood platelets, high levels of haemoglobin, headache, nosebleeds, small red blood vessels in the skin (telangiectasia), diarrhoea, dizziness and skin rash.
As with any medicine, the MHRA will keep the safety and effectiveness of sotatercept under close review.
Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website ( https://yellowcard.mhra.gov.uk/ ) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
