Brazil’s Anvisa Approves World’s First Weekly Insulin Awiqli for Diabetes
Anvisa has approved Awiqli, the first weekly insulin for adults with type 1 and 2 diabetes, produced by Novo Nordisk. The approval is based on successful clinical trials and highlights the drug’s effectiveness and safety for glycemic control. Awiqli awaits a nationwide launch in Brazil.
Brazil’s National Health Surveillance Agency (Anvisa) recently approved Awiqli, a groundbreaking weekly insulin treatment for adults with type 1 and type 2 diabetes. Manufactured by Novo Nordisk, this insulin is the first of its kind globally. However, a nationwide launch date has yet to be announced.
The approval was supported by the Onwards clinical trial program, which demonstrated Awiqli’s significant efficacy in managing glycemic levels in type 1 diabetes, showing results comparable to traditional daily basal insulins. Users can maintain stable glycemic control with just one weekly injection, according to the manufacturers.
Furthermore, Awiqli has also shown effective glycemic control and safety akin to daily insulins for patients with type 2 diabetes. The pharmaceutical company emphasized that insulin icodeca allows consistent glycemic management for patients of varying profiles, including those with renal issues. Notably, it did not present substantial increases in severe adverse reactions, such as hypoglycemia.
Awiqli has been previously approved by the European Medicines Agency (EMA) and in several countries, including Australia, Switzerland, Germany, Japan, and Canada. The company has submitted orders to the U.S. Food and Drug Administration for further evaluation. All medications from Novo Nordisk require a prescription and must be overseen by a qualified physician. Currently, no launch date has been confirmed for Brazil.
In conclusion, Brazil’s Anvisa’s approval of Awiqli marks a significant advancement in diabetes treatment, offering a weekly insulin option for adult patients suffering from type 1 and 2 diabetes. The approval is rooted in clinical trial evidence showcasing effective glycemic management alongside safety profiles similar to existing daily insulins. As the drug awaits its nationwide launch, it represents a prospective evolution in diabetic care.
Original Source: en.mercopress.com
