Anvisa Approves Awiqli: The First Weekly Insulin for Diabetes in Brazil
Anvisa has approved Awiqli, the first weekly insulin for type 1 and 2 diabetes patients in Brazil, with no launch date announced. The drug ensures effective glycemic control with a single weekly injection and has shown similar safety to daily insulins. Approved in several countries globally, the product will require prescriptions upon release.
Brazil’s National Health Surveillance Agency (Anvisa) has granted approval for Awiqli, a groundbreaking drug by Novo Nordisk, recognizing it as the first weekly insulin treatment intended for adults with type 1 and type 2 diabetes. Although no launch date has been announced, this approval marks a significant advancement in diabetes management.
The approval was contingent upon the positive outcomes from the Onwards clinical trial program, which indicated the drug’s efficacy in maintaining glycemic control in type 1 diabetes patients comparable to traditional daily basal insulin treatments. Patients achieved adequate glycemic levels with just one weekly injection.
In addition to its benefits for type 1 diabetes, Awiqli demonstrated safety and effective glycemic control in patients with type 2 diabetes. Novo Nordisk emphasized that the insulin icodeca provides stable glycemic control and is suitable for a diverse patient population, including those suffering from renal dysfunction, without a significant increase in serious side effects such as hypoglycemia.
Awiqli has already received endorsements from regulatory bodies outside Brazil, including the European Medicines Agency (EMA), and is approved in various countries including Australia, Germany, Japan, and Canada, demonstrating international recognition. Applications for evaluation have also been submitted to the U.S. Food and Drug Administration (FDA).
Novo Nordisk confirmed that Awiqli will only be available through prescriptions, ensuring medical supervision throughout the treatment process. However, the timeline for launching the product in Brazil remains unspecified.
The approval of Awiqli by Anvisa represents a noteworthy development in diabetes care, being the first weekly insulin treatment approved globally. The clinical trial results showcase its effectiveness and safety for individuals with both type 1 and type 2 diabetes, reflecting a progressive step towards enhancing glycemic control. Nonetheless, the absence of a definitive launch date in Brazil warrants attention as stakeholders await further announcements regarding its availability.
Original Source: en.mercopress.com
