US Launch of RemoSynch Implantable Pump for PAH Postponed Until 2018

Due to regulatory delays, the U.S. launch of United Therapeutics‘s implanted pump system for the delivery of Remodulin (treprostinil) for patients with pulmonary arterial hypertension (PAH) will be postponed until 2018.

“United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” Martine Rothblatt, PhD, United Therapeutics’ chairman and CEO, said in a news release. “We are sorry to have missed our 2017 launch target, but it is a small miss in the context of our providing more U.S. pulmonary arterial hypertension patients with helpful medicines than any other company.”

United Therapeutics and Medtronic have been collaborating in the development of Medtronic’s proprietary intravascular infusion catheter system, intended to be used by PAH patients for the intravenous delivery of the drug Remodulin. The system is referred to as the RemoSynch or Implantable System for Remodulin.

To introduce RemoSynch in the U.S., Medtronic and United Therapeutics have been pursuing parallel regulatory filings with the U.S. Food and Drug Administration (FDA) regarding the device and the drug, respectively.

Remodulin is a prostacyclin vasodilator — a class of drugs with the ability to dilate blood vessels — indicated for the treatment of patients with PAH in the World Health Organization (WHO) Group 1 classification system to improve symptoms associated with exercise and reduce clinical worsening.

United Therapeutics’ studies have demonstrated the effectiveness of Remodulin in several patient populations, namely PAH patients with the idiopathic or heritable form of the disease, patients with congenital systemic-to-pulmonary shunts-related PAH, and patients with connective tissue disease-related PAH.

Remodulin is indicated for continuous subcutaneous infusion administration or continuous intravenous infusion. Treprostinil is also available as an inhalation product (sold under the brand name Tyvaso).

Common adverse effects for treprostinil include cough, headache, nausea, throat irritation, flushing, temporary loss of consciousness or a drop in blood pressure, jaw pain, hypotension and edema. Since the drug has anticoagulation properties, those who are already on anticoagulants should consult a specialist before starting treatment.

PAH occurs when the pressure in the blood vessels leading blood from the heart to the lungs is too high. Although PAH is considered a rare disease, it has an estimated prevalence of 15 to 50 cases per 1 million people.