United Therapeutics Falls After Hypertension Pill Rejected
United Therapeutics fell 2.2 percent to $59.62 at 4 p.m. New York time. The Silver Spring, Maryland-based company has increased 25 percent in the past 12 months.
The Food and Drug Administration told United Therapeutics about the rejection of its treprostinil pill for pulmonary arterial hypertension in a so-called complete response letter, the company said in a statement today. United Therapeutics will immediately seek a meeting with the FDA to discuss the letter.
“We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner,” Martine Rothblatt, chairman and chief executive officer of the company said in the statement.
Treprostinil is already approved to treat the life- threatening disorder by injected, intravenous and inhaled administration.
When United Therapeutics received the first complete response letter in October, the FDA questioned whether the drug slowed the progress of pulmonary arterial hypertension in three final-phase studies and questioned the lack of a statistically significant effect on a six-minute walking test in two studies.
To contact the reporter on this story: Anna Edney in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Reg Gale at email@example.com