Pulmonary hypertension drug granted accelerated approval

June 3, 2002

United Therapeutics' Remodulin is approved for pulmonary hypertension

 

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Pulmonary hypertension drug granted accelerated approval

The Food & Drug Administration has granted accelerated approval to treprostinil (Remodulin Injection, United Therapeutics) to treat pulmonary arterial hypertension (PAH). Accelerated approval was based on the results of the largest double-blind, placebo-controlled trial ever conducted in patients with PAH.

The drug is a continuous subcutaneous infusion for PAH patients with New York Heart Association Class II-IV symptoms, to diminish symptoms associated with impairment in exercise ability. An analog of prostacyclin, treprostinil relaxes blood vessels in the lungs, improving blood flow and increasing exercise capability.

Infusion-site pain and infusion-site reaction were the most common side effects of treprostinil therapy reported in clinical trials. Treprostinil continues to be used by approximately 500 patients worldwide in open-label trials sponsored by United Therapeutics. Some patients have been taking the drug for almost four years.

Treprostinil is available through specialty pharmacies, including Priority Healthcare Corp. and Gentiva Health Services—United Therapeutics' U.S. distributors. The recommended average wholesale price (AWP) for the drug is $65 per milligram, with the medication in an aqueous formulation in a 20-ml vial. For more information, contact Priority Healthcare at (866) 4-PH-TEAM or Gentiva Health Services at (866) FIGHT-PH.

Treprostinil is the second drug cleared recently for PAH. The FDA approved bosentan (Tracleer, Actelion Ltd.) for this condition this past November.

Charlotte LoBuono

 

Charlotte LoBuono. Pulmonary hypertension drug granted accelerated approval. Drug Topics 2002;11:12.