Rybelsus approved for adults with type 2 diabetes in the EU

Following a positive recommendation from the European Medicines Agency’s advisory panel at the end of January this year, the European Commission has granted marketing authorization for Rybelsus (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise.

The marketing authorization, granted to Danish diabetes care giant Novo Nordisk (NOV: N), applies to all 27 European Union member states and the UK. The oral semaglutide adds to Novo Nordisk’s already marketed injectable formulation Ozempic, which last year generated global sales of around $1.65 billion, while Rybelsus, which gained approval in the USA in September last year, posted fourth-quarter 2019 revenues of $7 million as it continued to roll out.

Rybelsus is the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist. The approval is based on the results from 10 PIONEER clinical trials, in which Rybelsus after 52 weeks demonstrated statistically significant reductions in HbA1c versus sitagliptin, empagliflozin and liraglutide and with up to 4.3kg weight reduction. Across the PIONEER program, Rybelsus demonstrated a safe and well-tolerated profile, with the most common adverse event being mild to moderate nausea which diminished over time.