Research & Development
Independent DMC Okays Continuation of United Therapeutics Study of Orenitram
11 September 2017 - - Silver Spring, Maryland-based biotechnology company United Therapeutics Corp. (NASDAQ: UTHR) has been informed that the independent data monitoring committee (DMC) for the FREEDOM-EV study of Orenitram (treprostinil) extended-release tablets has completed a pre-specified interim safety and efficacy analysis, the company said.
The DMC did not identify any new safety concerns associated with Orenitram therapy, and recommended that the trial be continued as planned without modification.
FREEDOM-EV is a Phase 3, international, multi-center, randomized, double-blind, placebo-controlled, clinical worsening study of Orenitram in patients with pulmonary arterial hypertension receiving background oral monotherapy study (a phosphodiesterase type 5 inhibitor or an endothelin receptor antagonist).
In accordance with the study protocol and DMC charter, previous interim safety analyses were performed at scheduled intervals throughout the study and this interim safety and efficacy analysis was performed after approximately 75% of the target 205 adjudicated clinical worsening (morbidity or mortality) events occurred within the study.
United Therapeutics is intentionally blinded to the interim analysis data and will remain blinded to results of the study until after the study is completed.
The threshold for stopping the trial early for overwhelming efficacy was intentionally set high with the understanding that a more robust result, based on a larger number of clinical worsening (morbidity or mortality) events, could be obtained by the study continuing to completion.
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 US Food and Drug Administration has reviewed the interim clinical trial results and neither participated in the DMC's closed session deliberation.
Orenitram, an extended-release, oral tablet form of treprostinil, is the only FDA approved, orally administered prostacyclin analogue, and is the only oral PAH prostacyclin class therapy approved in the United States that is titratable to tolerability, without a dose ceiling.
United Therapeutics is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions.
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