The government has changed its approval for the efficacy and safety of Saxenda (ingredient: liraglutide), an obesity treatment by Novo Nordisk Korea.
Citing Saxenda’s long-term clinical trials SCALE and LEADER, the Ministry of Food and Drug Safety recently removed the label that the drug’s effectiveness lasts for a year.
According to Novo Nordisk Korea, the regulator deleted the statements, “The therapeutic effect of this medication is documented only for one year. The need for continuation of treatment should be reassessed every year,” based on SCALE clinical results.
The government also erased the statement that patients with a pancreatitis history should be careful to use the drug, based on the results of the three-year SCALE trials.
However, Saxenda had to maintain the warning phrases that acute pancreatitis was observed with the use of GLP-1 receptor agonists and that patients with suspected pancreatitis and acute pancreatitis should discontinue the medication.
Nova Nordisk Korea said it also enhanced clinical data on patients with heart and cerebrovascular diseases.
The LEADER study confirmed Saxenda’s five-year long-term efficacy in 9,340 patients with type-2 diabetes who have a high risk of developing cardiovascular diseases, the company said.