The marketing authorisation applies to all 27
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 vs sitagliptin, empagliflozin and liraglutide and with up to 4.3 kg weight reduction. Across the PIONEER programme, Rybelsus demonstrated a safe and well-tolerated profile, with the most common adverse event being mild to moderate nausea which diminished over time.
'We are very excited about the approval of Rybelsus as we can now offer people in
The launch of Rybelsus is expected to take place in the first EU countries in the second half of 2020.
About Rybelsus
Rybelsus (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1. Rybelsus is approved in the US,
Rybelsus is currently under review by several regulatory agencies, including the
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