WEGOVY (Novo Nordisk Pharmaceuticals Pty Ltd)
Product name
WEGOVY
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
Semaglutide
Registration type
EOI
Indication
Metabolic dysfunction-associated steatohepatitis (MASH)
Wegovy is indicated for the treatment of non-cirrhotic metabolic dysfunctionassociated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication was approved via the provisional approval pathway based on resolution of steatohepatitis and improvement in liver fibrosis. Continued approval of this indication depends on verification and description of clinical benefit in confirmatory trials.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine