Indonesian Regulator Approves REMITCH^® OD Tablets 2.5µg for Pruritus Relief

Tokyo, Japan, September 26, 2024 – Toray Industries, Inc., and Meiji Seika Pharma Co., Ltd., announced today that PT. Meiji Indonesian Pharmaceutical Industries, a subsidiary of the latter company, obtained regulatory approval in August, to import and market REMITCH® OD Tablets 2.5µg (generic name: nalfurafine hydrochloride; see note below) in Indonesia. This medication is for dialysis patients and patients with chronic liver disease, amongst those who finds the existing pruritus therapies and treatments ineffective. REMITCH® OD Tablets 2.5µg has already been marketed in Japan for dialysis patients and patients with chronic liver disease, amongst those who similarly finds the existing pruritus therapies and treatments ineffective. In January 2019, Toray and Meiji Seika Pharma signed an agreement to develop and market this medicine in Thailand and Indonesia, thereafter developing it in those countries. PT. Meiji Indonesian Pharmaceutical Industries filed an approval application with the Badan Pengawas Obat dan Makanan (BPOM) in March 2022. Having obtained the regulatory approval in August 2024, it will now market and provide necessary information concerning REMITCH® OD Tablets 2.5µg in Indonesia. In addition, Thai Meiji Pharmaceutical Co., Ltd. obtained import and marketing approval for dialysis patients amongst those who finds the existing pruritus therapies and treatments ineffective from the Food and Drug Administration of Thailand’s Ministry of Public Health in June 2023, and has already commenced its sales and information dissemination activities in Thailand this year. Through the marketing and information dissemination activities of REMITCH® OD Tablets 2.5µg, Toray and Meiji Seika Pharma will contribute to alleviating refractory pruritus for dialysis patients and patients with chronic liver disease, amongst those who finds the existing pruritus therapies and treatments ineffective. Note on REMITCH® OD Tablets Toray developed REMITCH® as the world’s first highly selective kappa opioid receptor agonist. People can take these orally disintegrating tablets with or without water, helping to enhance medication adherence among those with fluid restrictions.

The release as fetched from its publisher. toray.com ↗