United Therapeutics’ Lung Drug Rejected by U.S. FDA

United Therapeutics Corp., a maker of vascular-disease medicines, failed to win U.S. approval for an oral version of Remodulin to treat a lung disorder.

The shares fell as much as 16 percent in extended trading after the Food and Drug Administration rejected the drug, questioning whether it slowed the progress of the disease, pulmonary arterial hypertension, in three final-phase studies, the Silver Spring, Maryland-based company said today in a statement. The FDA also questioned the lack of a statistically significant effect on a six-minute walk distance in two studies.

United Therapeutics’ therapy is an oral version of treprostinil, which is already approved to treat the life-threatening lung disorder by injected, intravenous and inhaled administration. While the company said the FDA is unsure if an additional clinical trial would alter the agency’s impressions of the oral version, regulators recommended the company consider a fixed-dose design and more frequent dosing, if it decided to conduct another study, United Therapeutics said.

“We will continue using our best efforts to gain approval of oral treprostinil, and we will focus on doing so within the next four years,” Martine Rothblatt, chairman and chief executive officer of United Therapeutics, said. “We will convene with our experts over the next several weeks to decide which of several paths forward to pursue.”

United Therapeutics fell 9.9 percent to $48.02 at 5:12 p.m. New York time after declining as low as $45. The company dropped 2.2 percent to close at $53.28.

The FDA approved injectable Remodulin in 2002, according to the agency’s website.


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