Takeda’s subcutaneous vedolizumab nabs CHMP nod for maintenance of ulcerative colitis and Crohn’s
pharmafile | February 28, 2020 | News story | Medical Communications, Sales and Marketing | CHMP, EMA, Takeda, vedolizumab
Takeda’s subcutaneous formulation of its gut-selective biologic vedolizumab has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), it has emerged, which advocated for its use as a maintenance treatment for Moderate to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
The manufacturer also revealed that it plans to offer this subcutaneous formulation in both a pre-filled syringe and a pre-filled pen.
The European Commission is now set to review the case to approve the drug and will take the positive CHMP opinion into account. Though it is not bound by the ruling, final decisions are often in line with these recommendations; should the drug ultimately secure approval, it would become the first maintenance therapy available in Europe for UC and CD in both intravenous and subcutaneous formulations.
“Today’s positive CHMP opinion marks a key step forward in our goal to provide greater options to patients with ulcerative colitis and Crohn’s disease,” said Adam Zaeske, Head of GI Franchise at Takeda’s Europe and Canada Business Unit. “Ulcerative colitis and Crohn’s disease are life-long diseases and it is important that patients have treatment options that suit their different preferences and lifestyles. We look forward to the European Commission’s decision and the opportunity to bring a subcutaneous formulation of vedolizumab to these patients across Europe.”
Matt Fellows
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