FDA approves drug developed by United Therapeutics Corp.

Remodulin would be used for type of hypertension

May 23, 2002|By Julie Bell | Julie Bell,SUN STAFF

United Therapeutics Corp. said yesterday that the Food and Drug Administration has approved its drug Remodulin, a treatment for a potentially life-threatening disease that causes high blood pressure in the vessels between the heart and lungs.

The drug, which is continually pumped from a wearable "cassette" through a needle placed under the skin, will compete with GlaxoSmithKline's intravenously administered Flolan and Actelion Ltd.'s pill, Tracleer, as a treatment for pulmonary arterial hypertension. The disease affects approximately 50,000 people in Europe and North America, most of whom the company said are undiagnosed.

Remodulin is the first drug developed by United Therapeutics to be approved. The Silver Spring-based company, which announced the approval after the close of the market, did not provide estimates yesterday of how much revenue it expects the drug to generate. Its shares rose 32 cents to $13.65 yesterday on the Nasdaq stock market.

"We are pleased that our constructive work with the FDA has resulted in the approval of Remodulin for all symptomatic stages of the disease ... " said Roger Jeffs, the company's president and chief operating officer. "We are committed to continuing clinical trials to further evaluate the benefit of Remodulin in the treatment of this devastating condition."

The company agreed as a condition of approval to conduct a Phase IV clinical trial, a human test that will help verify and further characterize Remodulin's effects. In the trial, the company said it will compare the health of patients treated with Flolan - the oldest treatment on the market - with that of patients treated with Remodulin or a placebo

Patients with pulmonary hypertension often suffer severe fatigue and are unable to do simple household chores or even walk across a room.

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