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Wednesday, November 17, 2021

First allogeneic stem cell therapy approval in Japan

 In September 2021 Takeda Pharmaceutical's Alofisel (approved in the EU in 2018) was approved for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease.

This was Japan's first allogeneic stem cell therapy approval.

Today, Japan’s reimbursement policy panel approved the listing of Alofisel, with an NHI price of 5.62 million yen (~USD $50,000). It will join the NHI price list on Nov 25.

Alofisel, granted RMAT designation in 2019, has not yet been approved in the U.S.

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