Takeda has secured the European Commission (EC) approval to market its subcutaneous (SC) formulation of Entyvio (vedolizumab) to treat moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) in adults.
UC and CD are the two most common forms of inflammatory bowel disease (IBD), which are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract, with CD potentially progressing over time.
The current EC approval enables the use of Entyvio SC in the 27 member states of the European Union (EU), along with the UK, Norway, Liechtenstein and Iceland. The Japanese pharmaceutical firm is offering its Entyvio SC in both a pre-filled syringe and a pre-filled pen.
Takeda Europe and Canada business unit head Adam Zaeske said: “We are delighted that the European Commission has approved the subcutaneous formulation of Entyvio. This allows physicians and adult patients to choose the delivery method that works best for each individual patient.
“Takeda’s commitment to treating gastrointestinal disease means that we are always looking to innovate to provide further therapeutic options to better meet the needs of the patients we serve.”
Entyvio is a humanised monoclonal antibody intended to treat Crohn’s disease
Entyvio is a humanised monoclonal antibody that specifically blocks the alpha4beta7 integrin, to inhibit the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), and limits the capability of certain white blood cells to infiltrate gut tissues.
The regulatory approval was based on phase 3 VISIBLE clinical trial program which evaluated the safety and efficacy of an SC formulation of Entyvio as maintenance therapy.
Entyvio has shown adverse reactions including nasopharyngitis, headache, arthralgia, upper respiratory tract infection, bronchitis, influenza, sinusitis, cough, oropharyngeal pain, nausea, rash, pruritus, back pain, pain in extremities, pyrexia, fatigue, injection site reactions and anaphylaxis.
The company said that its Entyvio SC would benefit adult patients living with moderately to severely active UC and CD and it will work with regulatory agencies for rapid approval of the drug.
In addition to the current EC approval, Entyvio SC has been submitted for regulatory and currently being reviewed by other regulatory authorities around the world.
