Anvisa Approves Awiqli: The First Weekly Insulin for Diabetes Treatment

Anvisa has approved Awiqli, the world’s first weekly insulin produced by Novo Nordisk, for treating adult patients with type 1 and 2 diabetes. The drug shows efficacy in maintaining glycemic control with a single weekly injection. While it has already gained approval in several countries, a launch date in Brazil remains undisclosed.

Brazil’s National Health Surveillance Agency (Anvisa) has granted approval for Awiqli, a revolutionary weekly insulin developed by Novo Nordisk, aimed at treating adult patients with type 1 and type 2 diabetes. This innovative drug is recognized as the first weekly insulin injection in the world, although a launch date for availability across Brazil remains unspecified.

The approval was supported by the results of the Onwards clinical trial program, which showcased Awiqli’s efficacy in maintaining glycemic control for type 1 diabetes patients. The study concluded that patients could achieve levels of glycemic control similar to those provided by daily basal insulin with just one injection per week.

Moreover, Awiqli exhibited comparable safety and effectiveness for glycemic regulation in patients with type 2 diabetes. The manufacturer emphasized that insulin icodeca facilitated stable glycemic levels throughout the week with a singular weekly injection, catering to a range of patient profiles, including those with renal dysfunction.

Novo Nordisk highlighted that safety was paramount, noting that Awiqli did not lead to a significant rise in serious adverse events, such as hypoglycemia. This weekly insulin injection is already approved by the European Medicines Agency (EMA) and in countries like Australia, Switzerland, Germany, Japan, and Canada. Furthermore, it has been authorized for the treatment of type 2 diabetes in China, and requests for evaluation have been submitted to the U.S. FDA.

According to Novo Nordisk, all their medications must be dispensed by prescription and should be supervised by a licensed physician. The company reiterated that there is currently no confirmed date for the introduction of Awiqli in Brazil.

The approval of Awiqli by Anvisa marks a significant advancement in diabetes treatment, offering a groundbreaking approach to insulin administration with its weekly injection model. The drug has demonstrated effectiveness and safety comparable to standard daily insulins, potentially benefiting a broad spectrum of diabetes patients. As expectations build, stakeholders await further announcements regarding its launch in Brazil.

Original Source: en.mercopress.com