Brazil’s Anvisa has approved Awiqli, the first weekly insulin for type 1 and 2 diabetes, highlighting its effectiveness and safety. Results from clinical trials revealed that it provides glycemic control comparable to daily insulins. The launch date in Brazil is undetermined, and it will be available only by prescription.
Brazil’s National Health Surveillance Agency (Anvisa) has approved Awiqli, a groundbreaking weekly insulin for treating adults with type 1 and 2 diabetes, as reported by Agencia Brasil. This approval marks the introduction of the world’s first weekly insulin injection, although the nationwide launch date remains unspecified.
The approval of Awiqli is based on the Onwards clinical trial program, showcasing its effectiveness in controlling glycemic levels in type 1 diabetes patients, achieving results comparable to daily basal insulin. The manufacturer emphasized that patients maintained proper glycemic levels throughout the week with just one injection.
Moreover, Awiqli demonstrated both safety and effective glycemic control for type 2 diabetes, similar to daily insulins. Novo Nordisk highlighted that this treatment provided stable glycemic control throughout the week with a single injection and is suitable for patients with varying profiles, including those with renal dysfunction. Notably, the medication showed no significant increase in serious adverse events such as hypoglycemia.
Awiqli, known scientifically as insulin icodeca, has gained approval from the European Medicines Agency and in several countries, including Australia, Switzerland, and Canada. The company has also submitted orders to the FDA for evaluation. It is important to note that all Novo Nordisk medicines are prescription-based and must be administered under the supervision of licensed healthcare professionals. However, a launch date for Awiqli in Brazil has yet to be determined.
Anvisa’s approval of Awiqli represents a significant advancement in diabetes treatment, particularly with its innovative weekly dosing schedule. This new medication offers promising benefits for both type 1 and type 2 diabetes patients, allowing for stable glycemic control with a single weekly injection. Nevertheless, the launch date in Brazil remains uncertain, and healthcare professionals will play a crucial role in its prescription and usage.
Original Source: en.mercopress.com
