According to a notice distributed by the agency, the US Food and Drug Administration (FDA) has approved United Therapeutics Corp.'s pulmonary arterial hypertension therapy Remodulin (treprostinil sodium). A spokesperson for the FDA told Reuters Health that the approved indication covers NYHA class II-IV pulmonary arterial hypertension. The FDA approved the drug under subpart H, which allows for marketing clearance based on an effect on a surrogate endpoint, provided well-controlled postmarketing studies are conducted.
United Therapeutics received an approvable letter for Remodulin earlier this year after the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6-3 in August 2001 to recommend approval.Remodulin is a synthetic formulation of prostacyclin designed for subcutaneous infusion using a small device developed by Medtronic MiniMed Inc. of Minneapolis, Minnesota.
The drug will compete with GlaxoSmithKline's Flolan (epoprostenol), a synthetic form of prostacyclin delivered via an external pump and an intravenous catheter. United Therapeutics has claimed that Remodulin's delivery system helps reduce the risk of sepsis associated with the delivery of Flolan.
