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MHLW Designates Tacrolimus And Infiximab Orphan Drugs

This article was originally published in PharmAsia News

Executive Summary

The First Division of the Pharmaceutical and Food Sanitation Council of the Ministry of Health, Labor and Welfare May 26 designated Atellas' tacrolimus monohydrate and Remicade orphan drugs. Tacrolimus is applied to treat myasthenia gravis patients that have not received a thymectomy, and in combination for patients showing effects with steroids. Tacrolimus is now in PhaseIII trials in Japan. There are an estimated 15,000 to 20,000 MG patients in Japan. Remicade (infliximab) is applied to treat ankylosing spondylitis. An anti-TNF drug, infliximab is now in open clinical trials. Patients with AS in Japan are numbered in several thousands. Formal designations are estimated to be within a month. (Click here for more - Japanese language



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