EMA’s Human Medicines Committee Recommends Wegovy in Tablet Form
EMA’s human medicines committee (CHMP), part of the European Medicines Agency, decided at its meeting this week to recommend approval of Wegovy in tablet form. It is now for the European Commission to make the final decision.
Formally, the CHMP recommends that the existing marketing authorisation which Novo Nordisk currently holds in the EU for Wegovy in injectable form be extended to also cover Wegovy in tablet form for adults – available on prescription.
As is the case with Wegovy in injectable form, Wegovy in tablet form is also intended for a specific group of patients, characterised, among other things, by being overweight and having at least one weight-related comorbidity. The tablet must also be used in combination with diet and physical activity.
Clinical Trial Forms the Basis
The CHMP’s assessment is based on a clinical trial involving 307 overweight adults with at least one associated comorbidity.
Among other findings, the clinical trial showed that the safety profile of Wegovy in tablet form is comparable with that known from Wegovy in injectable form, and that side effects mainly occur at the beginning of treatment.
The CHMP’s assessment has now been sent to the European Commission, which will then decide whether Wegovy’s marketing authorisation should be extended. If it is, Novo Nordisk will be able to market Wegovy in tablet form in the EU.