Chugai's Enspryng gains first Asian approval, with MHLW clearance for NMOSD

The new drug application for Enspryng (satralizumab) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica).

Developed by Japanese drug major Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss pharm giant Roche (ROG: SIX), Enspryng was granted orphan drug designation in September 2019 and filed in November 2019 in Japan.

“NMOSD is a chronic autoimmune disease with limited treatment options and high unmet medical needs which causes visual impairment and motor disability in severe unpredictable relapse. Enspryng is an antibody drug with a novel mechanism of action to inhibit the signaling of IL-6, an inflammatory cytokine that is a key driver in NMOSD, and shown to be highly effective in prevention of relapse of NMOSD,” said Dr Osamu Okuda, Chugai’s president and chief operating officer, adding: “In addition, Enspryng, which was the first to apply our proprietary recycling antibody technology, can be subcutaneously administered every four weeks for convenience. We are confident that Enspryng will widely contribute to the treatment of people with NMOSD as a new treatment option.”