United Therapeutics Corporation, a biotechnology company, announced that Japan's Ministry of Health, Labour and Welfare has granted approval for Remodulin (treprostinil) injection for the treatment of pulmonary arterial hypertension (PAH) by subcutaneous and intravenous administration.
Remodulin will be sold in Japan under the brand name Treprost by Mochida Pharmaceutical Co., Ltd., under an exclusive distribution agreement with United Therapeutics.
"We are grateful for Mochida's diligent work in obtaining this approval in Japan," said Yu-Lun Lin, United Therapeutics' associate vice president and managing director, UTAsia. "We look forward to Mochida's launch of Treprost and to bringing this new therapeutic option to the PAH community in Japan."
Remodulin is a prostacyclin vasodilator indicated in the United States 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%).
Remodulin 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.