United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) have issued an approvable letter for Remodulin (treprostinil sodium) Injection for the treatment of pulmonary arterial hypertension. An approvable letter usually represents the final step before a drug receives FDA clearance for marketing in the United States.
The FDA has proposed drug labeling for pulmonary arterial hypertension consistent with the treatment of both primary and secondary pulmonary hypertension in patients with NYHA Class II-IV symptoms. The approvable letter also stated that the FDA intends to approve Remodulin with a requirement that United Therapeutics subsequently conduct a post-marketing controlled clinical trial to verify and further describe the drug's clinical benefit.
United Therapeutics is in final discussions with the FDA, the outcomes of which are expected to form the basis for approval of Remodulin in accordance with the FDA's accelerated approval regulations. Upon approval, Remodulin will be the first FDA-approved therapy for NYHA Class II pulmonary arterial hypertension patients.
United Therapeutics conducted the largest double blind placebo-controlled study in pulmonary arterial hypertension, a disease in which blood pressure in the pulmonary arteries rises to life-threatening levels. Approximately 50,000 people in North America and Europe are afflicted with forms of the disease. On August 9, 2001, FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval of Remodulin. United Therapeutics has submitted Remodulin marketing applications to health authorities in France, Switzerland and Canada. Additional international filings will follow approval in the U.S. and France.