United Therapeutics has announced that the FDA has approved a supplemental new drug application (sNDA) for Remodulin (treprostinil sodium) injection. The sNDA was filed by the sompany in satisfaction of the FDA's Subpart H accelerated approval requirement for a Phase IV post-marketing study to confirm the clinical benefit of Remodulin. The initial approvals of both subcutaneous and intravenous use of Remodulin were contingent upon the company's completion of that study.
The Phase IV study, which was successfully completed last year, involved the transition of patients from Flolan to either Remodulin or placebo. In the trial, 13 of 14 patients randomized to Remodulin were able to successfully transition from Flolan and complete the study without the need to re-institute Flolan therapy, compared to only one of eight patients randomized to placebo.