Oral treprostinil regulatory update
FDA issued a complete response letter for an NDA from United Therapeutics for oral treprostinil to treat pulmonary arterial hypertension (PAH). According to the company, the agency questioned the clinical importance of the 6-minute walk distance (6MWD) improvement in the Phase III FREEDOM-M trial, the inability to demonstrate an improvement in time to clinical worsening in all 3 of the product's Phase III studies, and the inability to demonstrate a statistically significant effect on 6MWD in the Phase III FREEDOM-C and FREEDOM-C2 studies. The company said FDA was "unsure whether an additional clinical study could alter these impressions, but if United Therapeutics did undertake an additional study, it should consider, among other things, a fixed dose design and more frequent dosing." The company plans to request a meeting with FDA. ...