United Therapeutics (UTHR) announced approval by the FDA of a new drug application, or NDA, for the use of Remodulin injection in the Implantable System for Remodulin, or ISR. The ISR has been developed under a collaboration with Medtronic (MDT). In December 2017, Medtronic received FDA approval of a premarket application, or PMA, for a proprietary intravascular infusion catheter to be used with its SynchroMed II implantable infusion pump and related infusion system components in order to deliver Remodulin for the treatment of pulmonary arterial hypertension, or PAH. Remodulin was originally approved by the FDA to treat PAH by continuous subcutaneous and intravenous routes of administration in 2002 and 2004, respectively, using external pumps. 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. 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.
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