United Therapeutics wins FDA OK for new hypertension drug

Shares of United Therapeutics Corp. rose nearly 12 percent Tuesday after the company revealed that it has won U.S. Food and Drug Administration approval to sell the drug Adcirca for the treatment of pulmonary arterial hypertension.

Clinical development of Adcirca was led by Eli Lilly & Co.

Adcirca is a prescription medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. Adcirca contains the same active ingredient as Cialis (tadalafil), which is marketed by Eli Lilly & Company to treat erectile dysfunction in more than 100 countries.

The American Lung Association says Pulmonary arterial hypertension can cause shortness of breath, chest pain and eventually heart failure. There is no cure. The disease is more common in women and often linked to other conditions such as heart or lung disease, infection with HIV, and autoimmune disorders.

Shares of Silver Spring-based United Therapeutics Corp closed at $74.43, up 11.86 percent.

Last November, United Therapeutics suffered a scientific blow with news of a three-month delay in a Food and Drug Administration decision on its inhaled Remodulin treatment. An experimental oral version of the drug failed late-stage clinical trials.

That's when the company signed a licensing agreement with Eli Lilly & Co. to develop and market its Cialis drug for the treatment of pulmonary arterial hypertension in the United States -- a deal that company officials said would double its revenues if the drug were to be approved for that disease by federal regulators.

United Therapeutics has a research and development outpost in Research Triangle Park.

Source : www.bizjournals.com

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