First-of-its-kind stem cell therapy, Alofisel, approved in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for the manufacture and marketing of Alofisel (darvadstrocel: code: Cx601) for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD).

Developed by Japanese pharma major Takeda Pharmaceutical (TYO: 4502), Alofisel becomes the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy to be approved in Japan

Alofisel, which is indicated for the treatment of patients who have shown an inadequate response to at least one existing medicinal treatment, came to Takeda with its $630 million acquisition of Belgian biotech TiGenix in 2018.

CD is a chronic inflammatory disease of the digestive system, which affects an estimated 70,700 people in Japan. People living with CD may experience complex perianal fistulas, which can cause intense pain, bleeding, swelling, infection, and anal discharge. Despite medical and surgical advancements, complex perianal fistulas in CD remain challenging for clinicians to treat.