According to a story from Healio, the investigational therapy sotatercept has been given Priority Review status from the US Food and Drug Administration (FDA). The therapy is in development as a treatment for pulmonary arterial hypertension, a rare disease. The decision was based on promising findings from a phase 3 clinical trial, in which patients that received sotatercept along with background therapy saw their risk of clinical worsening and death reduced by 84 percent.
Sotatercept is under development by Merck and is classified as an inhibitor of activin signaling. Prior data, which was presented at the American College of Cardiology, revealed that treatment with the therapy could also improve performance in 6-minute walk distance by an average of 40.1 m after a treatment period of 24 weeks.
Patients receiving the drug also outperformed the placebo group in eight of nine total secondary endpoints. The drug is projected to increase life expectancy by three times when compared to background therapy on its own.
The trial abstract was published in the New England Journal of Medicine.
About Priority Review
Therapies under review that show potential in trials to have major advantages over current therapies in terms of effectiveness or safety, and are developed to treat serious, life-threatening conditions, may receive FDA Priority Review. This status reduces the review duration from a standard 10 months to 6 months.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplant. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.