Bloomberg News

United Therapeutics Falls as FDA Rejects Oral Remodulin

October 24, 2012

United Therapeutics Corp. (UTHR:US) fell the most in 14 months after U.S. regulators rejected the company’s oral version of Remodulin to treat a lung disorder.

United Therapeutics decreased 16 percent to $44.99 at the close in New York, the largest single-day decline since Aug. 24, 2011. The shares had gained 13 percent this year through yesterday.

The Food and Drug Administration questioned whether the drug slowed the progress of the disease, pulmonary arterial hypertension, in three final-phase studies, the Silver Spring, Maryland-based company said in a statement yesterday. 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 yesterday. “We will convene with our experts over the next several weeks to decide which of several paths forward to pursue.”

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

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


Tim Cook's Reboot
LIMITED-TIME OFFER SUBSCRIBE NOW

Companies Mentioned

  • UTHR
    (United Therapeutics Corp)
    • $130.43 USD
    • -0.51
    • -0.39%
Market data is delayed at least 15 minutes.
 
blog comments powered by Disqus