The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sotatercept (Winrevair) to treat pulmonary arterial hypertension (PAH).
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.
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.
The new marketing authorisation was granted to Merck Sharp & Dohme (UK) Limited (MSD UK).
