Chugai files for additional indication of Enspryng in Japan

Japanese drugmaker Chugai (TYO: 4519) announced that it filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for an additional indication of “prevention of relapse in myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease” for Enspryng (satralizumab [genetical recombination)], a pH-dependent binding humanized anti-interleukin (IL)-6 receptor monoclonal antibody (MAb).

“MOG antibody-associated disease (MOGAD) is a rare autoimmune disease in which repeated relapses may leave neurological symptoms, such as visual field and vision impairment, as well as paralysis, causing long-term impacts on patients’ lives. In a global Phase III study, Enspryng reduced the risk of relapse by 68% compared with placebo. We will work closely with the regulatory authority so that we can deliver Enspryng to patients with this disease, for which there are currently no approved treatments, as soon as possible,” said Chugai’s president and chief executive, Dr Osamu Okuda.