In partnership with Mesoblast Limited, JCR Pharmaceuticals has filed to extend the marketing approval of TEMCELL®, a mesenchymal stem cell (MSC) wound healing product for patients with Epidermolysis Bullosa (EB).
JCR has received an orphan drug designation for subcutaneous treatment of TEMCELL® for EB, and are currently seeking a label extension for intravenous delivery of TEMCELL® in Japan. There is no cure for EB in the current market, but MSC therapy using TEMCELL® has shown promising signs in an investigator-initiated trial.
TEMCELL® was the first allogeneic cellular medicine to receive the full regulatory approval in Japan, previously indicated for treatment of acute graft versus host disease (aGVHD). JCR’s clinical trial data on TEMCELL® for EB in Japan will also aid Mesoblast’s development and commercialization of their MSC treatment for aGVHD.
With the good news from JCR’s clinical data on TEMCELL® in Japan, there is hope of creating the first ever effective treatment for EB, a rare genetic skin disorder that causes fragile skin that blisters from gentle friction or rubbing. (Source)
Join us at Biologics Manufacturing Japan to meet the experts keen on advancing the orphan drug market and get the latest updates on cell therapy in Japan.