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Takeda’s NDA for fomepizole gets approval in Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the new drug application (NDA) of Takeda Pharmaceutical's Fomepizole Intravenous Infusion 1.5g 'Takeda' (fomepizole), an alcohol dehydrogenase inhibitor, to treat ethylene glycol and methanol poisonings.

Fomepizole is marketed and distributed by Paladin Labs (Paladin) in Canada and is the standard treatment for ethylene glycol and methanol poisonings.

In 2011, Paladin and Takeda entered into a license and distribution deal for fomepizole, which was an ‘Unapproved New Drug in Japan’ at that time.

In December last year, Takeda submitted the NDA for fomepizole to the MHLW, which has requested pharmaceutical companies to develop the drug in Japan in accordance with the result of the conference ‘Unapproved New Drugs and New Indications with High Medical Needs’.

Ethylene glycol and methanol poisonings occur from the organic acid produced in the body when ethylene glycol or methanol is ingested.

Through this approval, the company contributed to initiatives to solve issues related to the ‘Unapproved New Drugs and New Indications in Japan’.

The company said that it will conduct All Cases Surveillance for patients with fomepizole over a period of time to collect safety and efficacy data of the drug after it is launched.