FDA approves new pulmonary arterial hypertension therapy
“Uptravi offers an additional treatment option for patients with pulmonary arterial hypertension,” Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “The FDA supports continued efforts to provide new treatment options for rare diseases.”
PAH is marked by high blood pressure (hypertension) in the arteries connecting the heart to the lungs. The disease is rare, and its chronic and progressive nature means patients often die from the condition or need a lung transplant.
Uptravi is an oral IP prostacyclin receptor agonist that works by relaxing the muscles in blood vessel walls to decrease pressure. The drug was the subject of a clinical trial involving 1,156 PAH patients.
Because PAH is rare, the FDA has granted Uptravi, a product of San Francisco-based Actelion Pharmaceuticals, orphan drug designation.
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