Anvisa Approves Awiqli: The World’s First Weekly Insulin for Diabetes

Brazil’s Anvisa has approved Awiqli, the first weekly insulin for type 1 and 2 diabetes by Novo Nordisk. Based on clinical trials, it shows effective glycemic control comparable to daily insulins. The drug has been approved in other countries and awaits a U.S. evaluation. A launch date in Brazil is still pending.

Brazil’s National Health Surveillance Agency (Anvisa) has granted approval for Awiqli, a weekly insulin developed by Novo Nordisk, to treat adult patients with type 1 and type 2 diabetes. This marks the first instance of a weekly insulin injection being introduced globally. However, a nationwide launch date has yet to be announced.

The approval was based on findings from the Onwards clinical trial program, which indicated that the medication effectively maintained glycemic control in type 1 diabetes patients, achieving levels comparable to daily basal insulin. According to the manufacturer, patients achieved stable glycemic levels with just one injection per week.

The insulin also exhibited safety and effective glycemic regulation in type 2 diabetes patients, mirroring the effects of daily basal insulins. Novo Nordisk emphasized, “Insulin icodeca allowed stable glycemic control throughout the week with a single weekly injection… showed no significant increase in serious adverse events, including hypoglycemia.”

Moreover, Awiqli has received approval from the European Medicines Agency and has been authorized in several countries, including Australia, Switzerland, Germany, Japan, and Canada. In China, it’s approved specifically for type 2 diabetes treatment. The FDA has also been approached for evaluation of the drug in the United States.

Novo Nordisk confirmed that all its medicines require a physician’s prescription, and treatments must be supervised by licensed professionals. As of now, there is no set launch date for Awiqli in Brazil.

The recent approval of Awiqli by Anvisa represents a significant advancement in diabetes care, enabling patients to manage their condition with a single weekly injection. Clinical trials support its effectiveness and safety profile, similar to daily insulin options. As Awiqli awaits its launch in Brazil, it has already gained recognition and approval in multiple other countries, showcasing global potential in diabetes management.

Original Source: en.mercopress.com