United Therapeutics resubmits oral drug candidate
United Therapeutics Corp., a Maryland-based company with operations in the Research Triangle Park, has resubmitted the new drug application for a candidate the U.S. Food and Drug Administration rejected last year.
The company announced Thursday that the FDA acknowledged the resubmission
of the drug candidate, an oral treatment for pulmonary arterial hypertension made with the compound treprostinil.
Last year, the company announced it had received notification from the FDA that the agency had declined to approve the application for an oral treatment for pulmonary arterial hypertension, a disorder characterized by high pressure in the pulmonary artery, which carries blood from the heart to the lungs.
United Therapeutics has three existing pulmonary arterial hypertension drugs. Its lead product is an injection treatment called Remodulin, which is made with the compound treprostinil, and it also sells an inhalation solution called Tyvaso that’s made with the same compound. It also sells as a tablet treatment called Adcirca made with a different active ingredient.
United Therapeutics is seeking approval from the FDA for the oral drug for treatment of pulmonary arterial hypertension made with treprostinil. The company has manufactured the drug candidate for clinical trials in the Research Triangle Park.