The European Medicines Agency (EMA) has accepted Takeda’s marketing authorisation application for its subcutaneous formulation of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease.
If approved, the drug would be the only maintenance therapy to offer the options of both intravenous or subcutaneous formulations across ulcerative colitis or Crohn’s disease.
The company proposes to make it available in both pre-filled syringe and pen options, helping provide greater choice in how patients receive therapy.
The application is based on the pivotal VISIBLE 1 Phase III study, which assessed the safety and efficacy of a subcutaneous formulation of Entyvio as maintenance therapy in 216 adult patients with moderately to severely active UC.
The results of the study found that 46.2% of patients receiving the maintenance therapy administered every two weeks achieved clinical remission, compared to 14.3% on placebo.
“This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe,” said Adam Zaeske, head, GI Franchise, Europe and Canada Business Unit, Takeda.
“If approved, a subcutaneous formulation of vedolizumab, together with the currently available intravenous option, will provide greater choice, enhancing the patient experience in line with their treatment preferences and lifestyle.”
Entyvio is a humanised monoclonal antibody designed to specifically antagonise the alpha4beta7 integrin, potentially limiting the ability of certain white blood cells to infiltrate gut tissues.