Takeda announced on Tuesday that its Phase 3 trial evaluating the efficacy of darvadstrocel, marketed as Alofisel, in the treatment of complex Crohn’s Perianal Fistulas did not meet its primary endpoint based on topline data.
Disappointing Outcome for Takeda’s Darvadstrocel Trial
The pharmaceutical company revealed that the primary endpoint of the study, which aimed to achieve combined remission at 24 weeks, was not attained. This setback has prompted Takeda to assess the financial implications of these results, including the potential impairment loss for intangible assets during the fiscal quarter ending on September 30.
Approved in Multiple Countries, but New Trial Results a Concern
Despite previous trials supporting its efficacy, Alofisel had already secured approvals in several regions such as the European Union, Israel, Switzerland, Serbia, the U.K., and Japan. The approval in Japan was contingent upon additional trial data. However, these latest trial results may raise questions and affect future decisions regarding the treatment’s application.
Future Dissemination of Full Study Findings
Takeda plans to present the complete findings of this study at an upcoming medical meeting or publish them in a reputable journal. The comprehensive results will shed more light on the outcomes and implications of this clinical trial.