Japan's JCR, Terumo gain PAFSC nods for regenerative medicine firsts under new law

Japan's JCR Pharmaceuticals has received a nod for JR-031, a human allogeneic mesenchymal stem cell-based regenerative medicine product, from the Pharmaceutical Affairs and Food Sanitation Council's (PAFSC) committee on regenerative medicine, the company said in a release. The committee made the recommendation on Sept. 2, along with a conditional approval for a Terumo product, marking both as the first to receive such a designation in Japan under the recently revised Pharmaceuticals and Medical Devices law. "JR-031 is a treatment of Acute GVHD, a severe complication arising from hematopoietic cell transplant, and JCR has been developing JR-031 in Japan utilizing the technology licensed-in from Osiris Therapeutics, Inc. in 2003," JCR said in the release. "Phase I/II clinical trial commenced in 2007, followed by Phase II/III trial in patients with severe acute GVHD which was completed in November 2013. Both studies demonstrated the efficacy and safety of JR-031 which led to JCR's filing for a marketing approval in September 2014." Terumo said in a release that its product is aimed at treatment of severe heart failure caused by ischemic heart disease that fails to respond to standard therapies. "Terumo began developing cell sheets in 2007 as part of its R&D on cardiac regenerative therapy," the company said in its release. "It commenced a clinical trial at three medical institutions in Japan in 2012 and completed the study in 2014. On October 30, 2014, Terumo applied to Japan's Ministry of Health, Labour and Welfare for approval to produce and market its skeletal myoblast sheets as a regenerative medicinal therapy for treating severe heart failure caused by chronic ischemic heart disease." Previously, Japan Tissue Engineering, a unit of Fujifilm, had won approval for two regenerative medicine products as devices under the previous regulatory structure. JCR release (PDF) | Terumo release