Oral treprostinil regulatory update
United Therapeutics said FDA accepted for review a resubmitted NDA for oral treprostinil to treat pulmonary arterial hypertension (PAH). The agency designated the NDA a Class 1 resubmission, with a March 31 PDUFA date. FDA issued a complete response letter for the product in October. According to the company, the agency questioned the clinical importance of the six-minute walk distance (6MWD) improvement in one Phase III trial of oral treprostinil and the inability to demonstrate a statistically significant effect on 6MWD in two other Phase III trials, as well as the inability to demonstrate an improvement in time to clinical worsening in all three trials. United Therapeutics said the resubmission contained a reanalysis of previously submitted data, but declined to disclose details (see BioCentury, Oct. 29, 2012). ...