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Breakthrough drug approved for Crohn’s disease patients in Japan

pharmafile | September 28, 2021 | News story | Manufacturing and Production  

Takeda has received approval to manufacture and market Alofisel® (darvadstrocel) in Japan. This drug will be used for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD).

Alofisel is the first expanded human allogeneic, adipose-derived, mesenchymal stem cell therapy to be approved in Japan. Through exhibiting immunomodulatory and local anti-inflammatory effects at the site of inflammation, it offers a new treatment option for complex perianal fistulas in patients with non-active or mildly active luminal CD, who have shown an inadequate response to at least one existing medicinal treatment.

The approval is based on data from two trials, the Japanese study Darvadstrocel-3002 and the ADMIRE-CD trial, conducted in Europe and Israel. The former was a Phase III uncontrolled study investigating the efficacy and safety of Alofisel for the treatment of complex perianal fistulas in 22 Japanese adult patients with luminal CD. The ADMIRE-CD trial was also a Phase III trial which revealed that Alofisel treatment was well-tolerated over 52 weeks, with a similar safety profile in the Alofisel group compared to the control group.

CD is a chronic inflammatory disease of the digestive system, affecting an estimated 70,700 people in Japan. Patients with CD may experience complex perianal fistulas, which causes intense pain, bleeding, swelling, infection, and anal discharge. Complex perianal fistulas in CD remains challenging for clinicians to treat, highlighting the importance of new, effective treatment options.

“We are delighted that Alofisel has been approved in Japan for the treatment of complex perianal fistulas in Crohn’s disease patients,” said Naoyoshi Hirota, General Manager of Takeda Development Center Japan. 

“Complex perianal fistulas are a challenging complication of Crohn’s disease, and the approval of the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy in Japan offers a potential cell-mediated closure option to patients who do not respond to conventional or biologic therapies.”

Lina Adams


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