Added benefit of Takeda’s Entyvio is not proven, says IQWiG

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Entyvio (vedolizumab) from Japan’s largest drugmaker Takeda Pharma (TYO: 4502) offers an added benefit over the appropriate comparator therapy in these patient groups, concluding that such an added benefit is not proven because the dossier contained no suitable data for any of the two therapeutic indications.

Crohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases. Vedolizumab is an option when conventional therapy is not tolerated or does not provide sufficient release of symptoms. This conventional treatment can also be a tumour necrosis factor alpha (TNFα) antagonist. Entyvio has been approved in Europe for patients with moderately to severely active Crohn’s disease or ulcerative colitis (The Pharma Letter May 27).

The Federal Joint Committee (G-BA) specified a TNFα antagonist (adalimumab or infliximab) as appropriate comparator therapy for both therapeutic indications. It is to be noted that it is possible to switch to a different TNFα antagonist or to adjust the dose in case of treatment failure with a TNFα Antagonist.