Brazil’s Anvisa has approved Awiqli, the first weekly insulin for treating type 1 and 2 diabetes. Developed by Novo Nordisk, its approval is based on clinical trials showing effective glycemic control. It is safe for various patient profiles and has been approved in several countries, with plans for FDA evaluation pending. No launch date is yet available for Brazil.
Brazil’s National Health Surveillance Agency, known as Anvisa, has granted approval for Awiqli, a groundbreaking drug developed by Novo Nordisk, intended for individuals afflicted with type 1 and type 2 diabetes. This medication is recognized as the first insulin to be administered weekly. However, a specific date for its nationwide availability has yet to be announced.
The approval is grounded in the outcomes of the Onwards clinical trial program, which exhibited the drug’s efficacy in managing glycemic levels in type 1 diabetes patients, achieving control levels comparable to those experienced with traditional daily basal insulin. Furthermore, patients administered this weekly treatment successfully maintained stable glycemic levels with just a single weekly injection.
In addition to its efficacy, the insulin demonstrated a safety profile similar to daily insulin regimens for type 2 diabetes patients. Novo Nordisk emphasized that “Insulin icodeca allowed stable glycemic control throughout the week with a single weekly injection, being effective in patients with different profiles, including those with renal dysfunction.” Notably, this insulin has already received approval from the European Medicines Agency (EMA) and in various countries, including Australia, Switzerland, Germany, Japan, and Canada, while also being endorsed for type 2 diabetes treatment in China.
Novo Nordisk has indicated that submissions for evaluation have been made to the U.S. Food and Drug Administration (FDA). It is critical to note that all medicines from Novo Nordisk will require a prescription and must be prescribed and monitored by a licensed medical professional. As of now, there are no set timelines regarding the drug’s launch in Brazil.
In conclusion, Anvisa’s approval of Awiqli marks a significant advancement in diabetes treatment, providing patients with a once-weekly insulin option that has proven both effective and safe. The drug’s efficacy in maintaining glycemic control and its promising safety profile further underscore its potential benefits for diabetes management in Brazil and beyond. Nevertheless, the launch timeline remains undefined, awaiting further developments from the manufacturer and regulatory agencies.
Original Source: en.mercopress.com
