For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA.
“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,” said the company’s chairman and CEO.
Treprostinil is a prostacyclin vasodilator that is already approved for the treatment of PAH in an injectable form (Remodulin) and in an inhalable form (Tyvaso). The FDA initially rejected the NDA for the drug last October.