MercoPress. South Atlantic News Agency

Brazil's Anvisa approves weekly insulin to treat diabetes 1 and 2

One weekly shot of the new drug is said to achieve the same results as current daily injections

Brazil's National Health Surveillance Agency (Anvisa) has approved the drug Awiqli, produced by the pharmaceutical company Novo Nordisk, to treat adult patients with type 1 and 2 diabetes, Agencia Brasil reported. It is the first weekly insulin shot in the world. There is no date for launching it nationwide.

The manufacturer said the approval was based on the results of the Onwards clinical trial program, which demonstrated the medication's effectiveness in controlling glycemic levels in patients with type 1 diabetes, achieving a control comparable to that of daily basal insulin.

Patients using this drug “maintained adequate glycemic levels throughout the week with a single injection,” the laboratory stressed.

This insulin also demonstrated safety and effective glycemic control, comparable to that of daily based insulins in patients with type 2 diabetes, it was explained.

“Insulin icodeca allowed stable glycemic control throughout the week with a single weekly injection, being effective in patients with different profiles, including those with renal dysfunction. In both cases, safety was a determining factor and Awiqli showed no significant increase in serious adverse events, including hypoglycemia,” Novo Nordisk underlined while noting that weekly insulin icodeca has already been approved for adults with type 1 and 2 diabetes by the European Medicines Agency (EMA) and in countries such as Australia, Switzerland, Germany, Japan and Canada. In China, the drug has been approved for the treatment of type 2 diabetes in adults. “The orders have also already been submitted to the FDA [Food and Drugs Administration, the U.S. regulatory agency] for evaluation,” the company also pointed out.

“All Novo Nordisk medicines must be sold under prescription, and the treatment must always be indicated and accompanied by a licensed physician. There is no date foreseen for the launching of the product in Brazil,” the pharmaceutical company also mentioned in a statement.