FDA approves United Therapeutics’ Remodulin label expansion

The supplemental new drug application (sNDA) was filed by United Therapeutics 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 (treprostinil sodium). The initial approvals of both subcutaneous and intravenous use of Remodulin were contingent upon United Therapeutics’ completion of that study.

The phase IV study, which was successfully completed last year, involved the transition of patients from GlaxoSmithKline’s Flolan to either Remodulin or placebo. In the trial, 93% of 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 13% of placebo-treated patients.

Based on these positive phase IV study results, the FDA has expanded Remodulin’s labeling to state that Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan. Previously, Remodulin had been approved as a continuous subcutaneous infusion or intravenous infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of pulmonary arterial hypertension in patients with NYHA class II-IV symptoms to diminish symptoms associated with exercise.