- The company announced that a phase 3 trial evaluating Orenitram in patients with pulmonary arterial hypertension, or PAH, will continue through completion after an independent interim analysis was conducted.
- Investors were hoping that the trial would be stopped early had the drug shown overwhelming efficacy.
United Therapeutics reports data monitoring committee did not identify any new safety concerns associated with Orenitram therapy; recommends trial continue as planned
- Co announced that the independent data monitoring committee for the FREEDOM-EV study of Orenitram (treprostinil) extended-release tablets had completed a pre-specified interim safety and efficacy analysis.
- The DMC did not identify any new safety concerns associated with Orenitram therapy, and recommended that the trial be continued as planned without modification.
- The DMC's recommendation to continue as planned reflects its review of all available safety and efficacy data, and was made independently. Neither United Therapeutics nor the FDA has reviewed the interim clinical trial results and neither participated in the DMC's closed session deliberation.
No comments:
Post a Comment