Histogenics successfully completed consultations with Japan Pharmaceuticals and Medical Devices Agency (PMDA) regarding the regulatory path for NeoCart® autologous cell therapy for the treatment of knee cartilage defects. Histogenics has nearly completed enrollment in a 245-patient Phase III clinical trial conducted under a Special Protocol Assessment with FDA, and seeks to leverage its U.S. clinical, preclinical and cGMP data on NeoCart into ex-U.S. markets.
Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in 2Q16, Histogenics initiated preparatory pre-consultations with the PMDA for the regulatory process. In 1Q17, PMDA agreed that the ongoing Phase III clinical trial with its 1-year primary endpoint could provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan.
Furthermore, PMDA agreed that a 30-patient, 1-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan.
Histogenics estimates 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee.
Histogenics successfully completed consultations with Japan Pharmaceuticals and Medical Devices Agency (PMDA) regarding the regulatory path for NeoCart® autologous cell therapy for the treatment of knee cartilage defects. Histogenics has nearly completed enrollment in a 245-patient Phase III clinical trial conducted under a Special Protocol...
Histogenics successfully completed consultations with Japan Pharmaceuticals and Medical Devices Agency (PMDA) regarding the regulatory path for NeoCart® autologous cell therapy for the treatment of knee cartilage defects. Histogenics has nearly completed enrollment in a 245-patient Phase III clinical trial conducted under a Special Protocol Assessment with FDA, and seeks to leverage its U.S. clinical, preclinical and cGMP data on NeoCart into ex-U.S. markets.
Shortly after reacquiring Japanese rights for NeoCart from Purpose Co. in 2Q16, Histogenics initiated preparatory pre-consultations with the PMDA for the regulatory process. In 1Q17, PMDA agreed that the ongoing Phase III clinical trial with its 1-year primary endpoint could provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan.
Furthermore, PMDA agreed that a 30-patient, 1-year confirmatory clinical trial in Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan.
Histogenics estimates 200,000 procedures annually in Japan for patients suffering from pain associated with cartilage defects in the knee.
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