Japan's PAFSC to review application from Takeda on glatiramer this week

Japan's Pharmaceutical Affairs and Food Sanitation Council's First Committee will review Takeda Pharmaceutical's glatiramer acetate drug approval application for relapsing multiple sclerosis on Aug. 28, a Ministry of Health, Labor and Welfare (MHLW) spokesman said. The original drug from Teva Pharmaceuticals ($TEVA) now sees generic competition in the U.S., but it has not been approved in Japan. The committee, or PAFSC, will also review an application for additional indication for Bayer Yakuhin's anticoagulant Xarelto. The drug application was not approved in February, pending a wider discussion on whether it should include treatment and relapse prevention of deep vein thrombosis and pulmonary embolism. The German firm also seeks a nod on pulmonary arterial hypertension treatment iloprost, an inhaled treatment backed by MHLW. A review of a pediatric dosage for pulmonary arterial hypertension treatment Tracleer from Actelion Pharmaceuticals ($ATLN) is also scheduled. PAFSC is an advisory committee that makes recommendations to MHLW. Other candidates that may be discussed at the next meeting include GlaxoSmithKline's ($GSK) dutasteride for male pattern baldness. More

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