Takeda Pharmaceutical Co Ltd (NYSE: TAK) released topline data from the Phase 3 ADMIRE-CD II study, assessing Alofisel (darvadstrocel) for complex Crohn's Perianal Fistulas (CPF).
Typical symptoms of perianal fistulas are anal pain with defecation, perianal itching, bleeding, and discharge of pus.
The study did not meet its primary endpoint of combined remission at 24 weeks.
The safety profile for darvadstrocel was consistent with prior studies, and no new safety signals were identified.
The study's full results will be presented at a future medical meeting or published in a peer-reviewed journal.
Alofisel is approved in the European Union, Israel, Switzerland, Serbia, the U.K., ...