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Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn's Perianal Fistulas - Iberonews

Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn's Perianal Fistulas - Iberonews
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Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn's Disease

Takeda Pharmaceutical Company Limited
Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn s Disease
Wednesday, February 10, 2021 12:15PM IST (6:45AM GMT)

Takeda Applies for Approval for the Company’s First Allogeneic Stem Cell Therapy in Japan
If Approved, Darvadstrocel Would Offer a Potential Cell-Mediated Closure Option for Adult Patients in Japan Who Do Not Respond to Conventional or Biologic Therapies for Complex Perianal Fistulas in Crohn’s Disease
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Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD). ....

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Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients wit

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10-Feb-2021
Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn’s Disease
Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel
In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn’s Disease

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Who Do Not Respond to Conventional or Biologic Therapies for Complex Perianal Fistulas in Crohn’s Disease[i]

Osaka, JAPAN, February 10, 2021 –Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD) ....

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