Brazil’s Anvisa Approves Awiqli: A Breakthrough Weekly Insulin for Diabetes

Brazil’s Anvisa has approved Awiqli by Novo Nordisk, the world’s first weekly insulin for type 1 and 2 diabetes. Its efficacy was supported by clinical trials, showcasing safe glycemic control. This insulin has received approvals from several countries, with pending evaluations by the U.S. FDA.

Brazil’s National Health Surveillance Agency, Anvisa, has granted approval for Awiqli, a new insulin medication developed by Novo Nordisk, designed for adult patients suffering from type 1 and type 2 diabetes. This innovative drug is noted as the first weekly insulin shot available globally, although a nationwide launch date has yet to be announced.
The approval is attributed to successful outcomes from the Onwards clinical trial program, which highlighted the drug’s ability to effectively manage glycemic levels in individuals with type 1 diabetes, achieving results similar to daily basal insulin. The manufacturer emphasized that patients could maintain sufficient glycemic control throughout the week with just one injection of this medication.
Moreover, Awiqli has demonstrated both safety and effective glycemic management for individuals with type 2 diabetes, comparable to that of daily insulin regimens. Novo Nordisk stated, “Insulin icodeca allowed stable glycemic control throughout the week with a single weekly injection.” This drug has shown effectiveness across various patient profiles, including those with renal dysfunction, while ensuring minimal risk of severe adverse events, such as hypoglycemia.
It is noteworthy that the medication has already received approval from the European Medicines Agency (EMA) and is available in several countries including Australia, Switzerland, Germany, Japan, and Canada. Additionally, it has been approved in China for treating type 2 diabetes in adults, with the U.S. FDA evaluation currently pending. Novo Nordisk reiterated that all its medications require a prescription and must be administered by a licensed healthcare provider. As of now, there is no confirmed launch date for Awiqli in Brazil.

The approval of Awiqli marks a significant advancement in diabetes treatment, providing a new weekly insulin option for patients. The findings from clinical trials underscore its efficacy and safety in managing glycemic levels for both type 1 and type 2 diabetes. With international approvals already in place, this medication has the potential to enhance diabetes management significantly, although the launch in Brazil remains to be determined.

Original Source: en.mercopress.com