Novo Nordisk's Rybelsus (oral semaglutide) has won European approval for type II diabetes, offering adults a new treatment option as the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist.
The decision allows doctors to prescribe the drug as an adjunct to diet and exercise for adults whose type II diabetes remains uncontrolled.
The approval is based on data from 10 PIONEER clinical trials, in which the drug showed “statistically significant reductions in HbA1c vs sitagliptin, empagliflozin and liraglutide and with up to 4.3kg weight reduction,” the firm noted.
The most common adverse event observed during the trials was mild to moderate nausea, which lessened over time.
“We are very excited about the approval of Rybelsus as we can now offer people in Europe living with type II diabetes the first and only GLP-1 in a tablet,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer.
“Based on its strong clinical profile, we believe Rybelsus has the potential to set a new standard for the treatment of type II diabetes, as millions of people are currently not achieving target blood sugar levels on available oral antidiabetic medications.”
The launch of Rybelsus is expected to take place in the first EU countries in the second half of 2020.