RESEARCH TRIANGLE PARK – United Therapeutics Corp. (Nasdag:UTHR) has received approval from the U.S. Food and Drug Administration (FDA) of its New Drug Application (NDA) for the use of Remodulin injection in its implantable system for treating pulmonary arterial hypertension (PAH).
PAH is a life-threatening disease of high blood pressure in the arteries carrying blood from the heart to the lungs. It gets worse over time and can make ordinary tasks such as walking, climbing stairs or toting grocery bags difficult for the sufferer.
The FDA approved Remodulin to treat PAH via continuous subcutaneous administration in 2002 and by continuous intravenous methods in 2004, both methods using external pumps. According to the company, “In the case of intravenous users, the therapy can be very burdensome and brings a risk of sepsis due to the use of a central indwelling catheter.”
United Therapeutics, based in Silver Springs, MD, and Research Triangle Park, developed the implantable system for Remodulin (ISR) with Medtronic (NYSE:MDT), which the FDA approved in 2017.
The company states that “The ISR provides patients a new option for delivery of intravenous Remodulin, where the entire delivery system is implanted into the body and will be refilled by healthcare professionals at intervals of up to 16 weeks depending on the patient’s dose, using a syringe needle through the patient’s skin.”
“We are extremely excited to offer this new option to patients suffering from PAH,” said Martine Rothblatt, Ph.D., chair and CEO of United Therapeutics, in a statement. “During the course of the DelIVery study, we received considerable physician and patient interest in the ISR. We are grateful to our collaborators at Medtronic for reaching this milestone and look forward to continuing our collaboration.”
