United Therapeutics Corporation, a biotechnology company, announced that Medtronic, Inc. has submitted a pre-market approval application to the US Food and Drug Administration (FDA) for the use of Medtronic's SynchroMed II implantable drug infusion system (including a newly developed catheter) for use with United Therapeutics' Remodulin (treprostinil) Injection delivered intravenously to patients with pulmonary arterial hypertension.
United Therapeutics plans to submit to the FDA a supplement to its New Drug Application for Remodulin in January 2015, in order to amend Remodulin's labeling to support the use of the drug with the SynchroMed II implantable drug infusion system.
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.
In patients with PAH requiring transition from Flolan (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.