A new treatment, Sotatercept, for pulmonary arterial hypertension (PAH) has recently been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA)
By approving this new treatment, the MHRA is offering new hope to patients who suffer from this condition, offering them a new option to help manage the effects of PAH and improve the quality of their lives.
What is pulmonary arterial hypertension and how does Sotatercept help?
PAH is a chronic condition that leads to high blood pressure in the arteries and lungs, which makes it harder for the heart to pump blood through the lungs.
Symptoms of PAH include shortness of breath, fatigue, dizziness and reduced ability to perform physical activities.
Over time, it can cause serious damage to the heart, and if it is left untreated, it can be fatal. In the past, treatment options for PAH have been limited, and there is a strong need for new treatments that can improve patients’ physical function and overall well-being is strong.
Sotatercept works by targeting the mechanisms behind the narrowing of blood vessels in the lungs, which is a key feature of PAH. This medication helps reduce the narrowing, making it easier for the heart to pump blood into the lungs. Over time, this will improve the exercise capacity, allowing patients to be more physically active. Sotatercept is used alongside over medicines for PAH and is recommended for adults with moderate to severe limitations in physical activity due to the condition.
The treatment is given through self-injection every three weeks. Patients receiving this treatment will be guided by their doctors, who will guide them on the correct dosage and schedule. This will allow the treatment to be tailored to each individual. To ensure this treatment’s benefits are maximised, patients must stick to the treatment plan set by their doctors.
Clinical trial results
Sotatercept was approved based on the results of a large clinical trial involving 323 adult patients with PAH. In the study, the Sotatercept showed significant benefits compared to the placebo when addressing exercise capacity.
The main measure used in the test was a six-minute walk test, a standard way to assess how far a person can walk in six minutes to indicate their functional ability. After 24 weeks of treatment, patients who received Sotatercept walked an average of 34 meters further than those who received the placebo. The median difference between the two groups was even greater, with Sotatercept patients walking an average of 40.8 meters further.
The results were promising; the ability to walk longer distances shows improved health and daily function for people with PAH. This makes Sotatercept a valuable addition to the treatment options for PAH.
Common side effects and self-monitoring
Sotatercept has side effects, the most common being low blood platelet counts, headaches, nosebleeds, skin rashes, dizziness and gastrointestinal issues like diarrhoea.
These side effects were observed in more than 10% of patients using the drug. Patients need to monitor any changes in their health and report any side effects to the doctors, pharmacies or nurses.
The MHRA also encourages patients to report side effects through the Yellow Card Scheme, which helps ensure continued safety monitoring of new treatments.
The future of PAH treatment with Sotatercept
The approval of Sotatercept offers new hope to patients living with PAH, providing them with a new treatment to manage this disease. As with most new treatments, the safety and long-term effects will continue to be monitored.
Patients who are considering Sotatercept as part of their treatment plan should discuss it closely with their healthcare team to better understand how it may benefit their specific condition.
