Fomepizole , an alcohol dehydrogenase inhibitor , is marketed and distributed by Paladin Labs Inc. ( "Paladin" ) in Canada and is the standard treatment for ethylene glycol and methanol poisonings. In May of 2011, Paladin and Takeda entered into a licens e and distribution agreement in Japan for the drug, which was an " Unapproved New Drug in Japan " at that time.
In December of 2013, Takeda submitted the NDA to the M inistry of Health, Labour and W elfare ( " M HLW " ) , followed by its approval in September of 2014. Fomepizole is one of the drugs which the MHLW requested pharmaceutical companies to develop in Japan in accordance with the result of the conference "Unapproved New Drugs and New Indic ations with High Medical Needs . " Therefore, Takeda developed the drug with a grant for development expenditures of the drug from the Pharmaceutical Development Support Center.
Ethylene glycol and methanol poisoning s occur from metabolic acidosis caused by the organic acid created in the body when ethylene glycol or methanol is ingested. Without appropriate diagnosis and t reatment , this may result in renal failure and visual loss, or even death. The number of patients in Japan is estimated to be up to several dozen per year.
"As a pharmaceutical company, we have been working to reduce concerns of ‘ Unapproved New Drugs and N ew I ndications in Japan ‘ , and the result is that we have launched the product ," said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda.
"We will contribute to the emergency treatment in Japan by the launch, and are committed to continuing its efforts to deliver medicines which patients and health care professionals are waiting."
Takeda will conduct All Cases S urveillance for patients with fomepizole over a period of time to collect safety and efficacy data of the drug.