The Remunity™ Pump for Remodulin®
United Therapeutics and DEKA Research & Development Corp. proudly announce the clearance of the Remunity Pump for Remodulin by the US Food and Drug Administration (FDA). Launch preparations are underway with the anticipated timeline of July 2020.
Remunity is a discreet, subcutaneous delivery system designed for adults (age 22 years and greater) with pulmonary arterial hypertension (PAH). The cassettes, which contain enough drug for up to 3 days (72 hours), arrive from the Specialty Pharmacy prefilled, eliminating the need for the patient to mix or fill. Remunity is small, water resistant, and programmed using a wireless remote making it safe and simple to use.
Remunity is the latest advancement from United Therapeutics to improve treatment options for PAH patients.
More information about United Therapeutics, DEKA, and Remunity may be found here.
For Important Safety Information on Remunity, please click here.READ PRESS RELEASE
United Therapeutics Announces FDA Approval of Updated Label for Orenitram Reflecting Results of the FREEDOM-EV Study
Orenitram, the oral formulation of treprostinil, was approved by the FDA in 2013. Orenitram was indicated to improve PAH patients’ exercise capacity when used as a monotherapy and has been an important part of the PAH treatment armamentarium since it was approved. On October 21, 2019, our company announced that the U.S. Food and Drug Administration (FDA) 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 (PAH). FREEDOM-EV was a phase 3, international, multi-center, randomized, double-blind, placebo-controlled, event-driven clinical worsening study of oral treprostinil in patients with PAH receiving background oral monotherapy. The new label for Orenitram reflects that treatment with Orenitram resulted in a significant delay in disease progression when used in conjunction with an approved oral background PAH therapy. We are excited about this approval and the confidence that it will provide physicians and patients in the efficacy and benefit of Orenitram.READ PRESS RELEASE
The Implantable System for Remodulin®
In 1996, United Therapeutics set out to change the future for people impacted by PAH. More than 20 years later, we remain committed to developing innovative treatments that aim to improve the lives of PAH patients including the joint development of the Implantable System for Remodulin® (ISR) with Medtronic.
Our initial expectation was to launch ISR at the PAH centers involved in the clinical trial with broader expansion of the program throughout 2020. Based on recent communications from the FDA, Medtronic will not be able to satisfy conditions to its pre-market approval (PMA) in 2020. As a result, we now estimate initial implantations will occur in 2021.
The collaboration between United Therapeutics and Medtronic remains strong and both companies look forward to the launch of the ISR.
For Important Safety Information on ISR, please click here.READ PRESS RELEASE