FDA Approves Takeda’s Biologics EntyvioBy
Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., report FDA approval for Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis
(UC) and adult patients with moderate to severe Crohn‘s disease (CD) . Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response.
Entyvio is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells. Integrin receptors function as bridges for cell-cell interactions. Entyvio blocks the interaction of a specific integrin receptor (expressed on circulating inflammatory cells) with a specific protein (expressed on cells in the interior wall of blood vessels), and thereby blocks the migration of those circulating inflammatory cells across those blood vessels and into areas of inflammation in the gastrointestinal tract.
In March 2014, Entyvio received a positive opinion for the treatment of adults with moderately to severely active UC and CD from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and Takeda is awaiting response from the European Commission on approval for Marketing Authorisation.