United Therapeutics Gets Approval for Remodulin - TheStreet

United Therapeutics

(UTHR) - Get Report

said late Wednesday that it has received final approval from the Food and Drug Administration for its drug Remodulin to treat pulmonary arterial hypertension.

Pulmonary arterial hypertension is a disease in which elevated blood pressure in the lungs causes shortness of breath and heart damage. About 50,000 people in North America and Europe suffer from various forms of the life-threatening disease, according to the company.

Remodulin, given by injection, was approved as a treatment for pulmonary arterial hypertension in patients to diminish symptoms associated with exercise. United Therapeutics agreed as a condition of approval to conduct a postapproval, controlled clinical trial to verify and further describe the drug's clinical benefits.

Doctors will not likely use Remodulin as a first-line treatment for the disease. Last November, Swiss biotech firm Actelion received FDA approval for Tracleer, which is an oral drug.


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also markets an injectable drug, Flolan, but the drug must be given to patients directly into a vein. Remodulin, by comparison, is administered by subcutaneous injection.

Shares of United Therapeutics closed Wednesday at $13.65, before news of the approval was announced. Notably, the company's stock has risen about 31% since the beginning of the year, a rare exception in the battered biotech sector.