Posted by Michael Wonder on 21 Oct 2019
United Therapeutics announces FDA approval of updated label for Orenitram reflecting results of FREEDOM-EV study
21 October 2019 - United Therapeutics today announced that the U.S. FDA has approved a supplement to the new drug application for Orenitram (treprostinil) extended release tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension.
The FDA-approved labelling has now been updated to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy. The primary efficacy endpoint of the FREEDOM-EV study was time to first clinical worsening (morbidity or mortality) event.
The new label notes that treatment with Orenitram resulted in a significant increase in the time to first clinical worsening event compared with patients who received placebo, which was associated with a reduction in the risk of an event. The treatment effect on time to first clinical worsening due to disease progression was consistent across subgroups.
