Takeda : Phase 3 Study Of Alofisel In Complex Crohn's Perianal Fistulas Fails To Meet Main Goal

(RTTNews) - Takeda (TAK) said that the Phase 3 ADMIRE-CD II study, assessing the efficacy and safety of Alofisel (darvadstrocel) for the treatment of complex Crohn's Perianal Fistulas, did not meet its primary endpoint of combined remission at 24 weeks.

The safety profile for darvadstrocel was consistent with prior studies and there were no new safety signals identified, the company said in a statement.

Alofisel is approved in the European Union, Israel, Switzerland, Serbia, United Kingdom and Japan based on positive data from the previously completed ADMIRE-CD study. The approval in Japan is also based on positive data from the Japanese study, Darvadstrocel-3002.

Takeda said it is continuing to assess the financial impacts of the study results, including impairment loss for intangible assets, on the fiscal quarter ended September 30, 2023.

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