AnGes, Inc. Submits Application for Marketing Approval to PMDA for HGF Gene Therapy for Critical Limb Ischemia
January 23, 2018 at 03:11 am
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AnGes, Inc. announced the submission of an application for marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for HGF plasmid, an investigational gene therapy for the treatment of critical limb ischemia (CLI), the most severe condition of peripheral arterial disease. The submission is based on the positive results from the randomized, placebo-controlled phase 3 trial and investigator-led clinical study conducted in Japan. AnGes anticipates being granted conditional approval under the regulatory scheme of “Approval with Conditions and Time Limit” for regenerative medicines. The review process is expected to take approximately one year. HGF plasmid has the potential to be one of the first gene therapy products to be approved for a non-genetic disease with chronic conditions. AnGes grants to Mitsubishi Tanabe Pharma Corporation the marketing rights to HGF plasmid for peripheral arterial diseases including CLI in Japan and the US. Once approved, Mitsubishi Tanabe will be responsible for the sales and marketing of the product.
AnGes, Inc., formerly AnGes MG, Inc., is a Japan-based company mainly engaged in the development of genetic medicines. The Company is involved in the development of hepatocyte growth factor (HGF) genetic medicines, NF-KB decoy oligo and hemagglutinating virus of Japan envelope (HVJ-E) non-viral vector, among others. As of December 31, 2012, the Company had four consolidated subsidiaries. On January 31, 2013, the Company sold a 95.3% stake of a Osaka-based subsidiary to ISHIHARA SANGYO KAISHA LTD.