Anvisa Approves Awiqli: The World’s First Weekly Insulin for Diabetes Treatment
Anvisa has approved Awiqli, the first weekly insulin for adults with type 1 and 2 diabetes, developed by Novo Nordisk. The drug’s approval is based on clinical trial results demonstrating effective glycemic control with a single weekly injection. Awiqli has global approvals and is currently awaiting a launch date in Brazil.
Brazil’s National Health Surveillance Agency (Anvisa) has granted approval for Awiqli, a novel weekly insulin developed by Novo Nordisk, aimed at treating adults with type 1 and type 2 diabetes. This medication is notable as it represents the first weekly insulin shot available globally. However, a definitive launch date for its availability throughout Brazil has yet to be announced.
Approval for Awiqli was founded on the results from the Onwards clinical trial program, which illustrated the drug’s efficacy in regulating glycemic levels for type 1 diabetes patients, achieving results that are comparable to traditional daily basal insulin. The manufacturer emphasized that patients administering this treatment “maintained adequate glycemic levels throughout the week with a single injection.”
In addition to its application for type 1 diabetes, the insulin product has demonstrated safety and effective glycemic management, matching the performance of daily basal insulins for type 2 diabetes patients. Novo Nordisk highlighted that the weekly insulin icodeca enabled stable glycemic control through a singular weekly injection, also effective for diverse patient profiles, including individuals with renal complications. Notably, safety was underscored, as Awiqli did not lead to a significant increase in serious adverse events, such as hypoglycemia.
Weekly insulin icodeca has received prior approvals from the European Medicines Agency (EMA) and in countries including Australia, Switzerland, Germany, Japan, and Canada. In China, the drug has been specifically approved for treating type 2 diabetes in adults. Furthermore, Novo Nordisk has indicated that applications have been submitted to the U.S. Food and Drug Administration (FDA) for assessment.
Novo Nordisk reiterated that all its medications require a prescription, with treatment administration to be supervised by a licensed healthcare professional. As of now, no timeline for the product’s launch in Brazil has been established.
In conclusion, Anvisa’s endorsement of the weekly insulin Awiqli marks a significant advancement in diabetes management for adults with type 1 and type 2 diabetes in Brazil. Highlighting its efficacy, safety, and compliance with global standards, Awiqli begins a new chapter in diabetes care, although a launch date remains undecided.
Original Source: en.mercopress.com
