Strong Phase 3 data for Takeda’s subcutaneous Entyvio in moderate to severe Crohn’s disease

pharmafile | February 17, 2020 | News story | Research and Development, Sales and Marketing Crohn’s disease, Entyvio, Takeda, crohn's disease, pharma 

Takeda has shared positive new Phase 3 data on a subcutaneous formulation of its gut-selective biologic Entyvio (vedolizumab) as a maintenance therapy for moderately to severely active Crohn’s disease (CD) in adult patients.

The company examined participants who had received two doses of Entyvio intravenous induction therapy and achieved clinical response after six weeks. These included patients who both had and had not previously received anti-tumor necrosis factor-alpha therapy.

The findings revealed that 48% of patients receiving Entyvio achieved clinical remission after 52 weeks of treatment – significantly more than with placebo at 34.3% – meeting the trial’s primary endpoint.

Furthermore, Entyvio recorded an enhanced clinical response rate of 52% compared to 44.8% with placebo after the same period.

“These results suggest that the investigational subcutaneous formulation of gut-selective vedolizumab can provide a new treatment modality for patients who might prefer a therapy that can be self-administered outside of the hospital setting,” commented Dr Séverine Vermeire, Head of the Department of Chronic Diseases & Metabolism at the KU Leuven and Honorary Member of ECCO.

Takeda confirmed that it has submitted an application to global authorities for regulatory review of the subcutaneous formulation of Entyvio.

“These data indicate that the investigational subcutaneous formulation of vedolizumab seems to have a similar safety profile to the intravenous formulation,” remarked Dr William Sandborn, Director of the Inflammatory Bowel Disease Center at the University of California. “If approved, subcutaneous vedolizumab, together with the intravenous formulation, could provide more choice to patients in how they receive their therapy, helping to meet their individual needs and preferences.”

Matt Fellows

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