The sotatercept received US Food and Drug Administration (FDA) approval in adult patients with Pulmonary Arterial Hypertension (PAH), Type I based on World Health Organization (WHO) classification*. It is a biologic inhibitor of activin signaling that was studied in the STELLAR clinical trial and targets the cause of the disease.
Sotatercept, which has been granted Breakthrough Therapy Designation by the FDA, represents a new therapeutic class and works by improving the balance between pro- and anti-proliferative signaling to regulate the proliferation of vascular cells that characterizes PAH.
Phase 3 drug for Pulmonary hypertension
The FDA approval was based on the results of the Phase 3 STELLAR study, which compared sotatercept with placebo, both in combination with standard therapies in adult patients with PAH. The results showed that adding sotatercept to standard treatment increased the distance patients might walk in 6 minutes by 41 meters and reduced the risk of death from any cause or clinical worsening of PAH by 84%, compared to standard treatment.
It is worth noting that sotatercept is administered once every three weeks by subcutaneous injection. It can be administered by the patients themselves or their caregivers, following appropriate guidance, training and monitoring by a healthcare professional.
Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension is caused by high blood pressure in the pulmonary arteries, which are responsible for carrying blood from the heart to the lungs. In sufferers, the thickness of the arteries increases or there is a blockage and a lack of blood flow. This condition can cause damage to the right part of the heart, which supplies blood to the pulmonary arteries (PAH Type I, according to WHO), can result in right-sided heart failure and can be fatal. PAH can occur on its own, but is more common in people who have another heart or lung condition. This complicates diagnosis and treatment. It often requires the contribution of Health professionals from various fields of Medicine (cardiologists, pulmonologists, etc.).
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