Reuters: Regulatory News: FDA rejects United Therapeutics' oral hypertension drug again

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FDA rejects United Therapeutics' oral hypertension drug again Mar 25th 2013, 11:41 March 25 | Mon Mar 25, 2013 7:41am EDT March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down 6 percent before the bell to $57. The drugmaker did not say it would quit pursuing a marketing approval for the tablet. "We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said. The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies. United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs. Remodulin, the company's lead product, accounted for half of United Therapeutics's revenue last year. The company also sells Adcirca, an oral tablet to treat PAH. Oral versions are usually preferred over other forms due to their ease of administration.

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