United Therapeutics’ Remodulin Study OK’D

United Therapeutics said Monday it has been OK’d on a study needed for accelerated approval of hypertension drug Remodulin.

The company also said it has also been granted expanded labeling for its treprostinil sodium injection, indicated for the treatment of pulmonary arterial hypertension.

We are pleased to have successfully completed our Subpart H accelerated approval efficacy commitment, said Roger Jeffs, president and chief operating officer of United Therapeutics. This study confirms the clinical benefit of Remodulin in pulmonary arterial hypertension patients, provides expanded labeling specific to Flolan transition, and removes Remodulin’s conditional approval status, he said.

United Therapeutics’ postmarket, phase 4 study — finished last year — tested Remodulin in patients who were transitioned from Flolan to either Remodulin or placebo.

In the study, 13 of 14 patients randomized to Remodulin were able to successfully transition from Flolan and complete the study without the need to go back on Flolan, compared to only one of eight patients who received placebo, the company said.

Based on these data, United Therapeutics can include in the drug’s labeling the phrase Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan; the risks and benefits of each drug should be carefully considered prior to transition.