Application filed in Japan for an additional indication for Treprost inhalation solution for pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema
Mochida Pharmaceutical Co., Ltd. announced that Mochida filed an application for approval of an additional indication for Treprost Inhalation Solution 1.74mg (generic name: treprostinil; development code: MD-711) for pulmonary hypertension (PH) associated with interstitial lung disease (ILD) or combined pulmonary fibrosis and emphysema (CPFE), to the Japanese Ministry of Health, Labour and Welfare (MHLW)
PH is a general term for pathological conditions in which elevated pulmonary artery pressure is observed. PH associated with ILD or CPFE, is classified into the third group of PH due to pulmonary disease and/or hypoxia among the five groups of PH based on the causes and pathologies. Due to the poor prognosis, early therapeutic intervention is necessary, but there are no drugs approved for the indication of this disease in Japan.
Mochida obtained the distribution rights for the product from United Therapeutics Corporation in 2017 and has been marketing it in Japan as a treatment for pulmonary arterial hypertension (PAH) since early 2023. In the United States, the product has been marketed as Tyvaso for the indication of PAH since 2009, and the indication for PH associated with ILD (including CPFE) was added in 2021. Treprostinil has been designated as an orphan drug by the MHLW for the expected indication of PH associated with ILD (including CPFE).
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