JAKARTA - Novo Nordisk announced that the US FDA has approved Novo Nordisk's weekly long-acting basal insulin. The insulin is a basal insulin with 700 units/mL injection that has received FDA approval. This insulin is indicated as an adjunct therapy to diet and exercise to help improve glycemic control (blood sugar) in adults with type 2 diabetes.
The FDA's approval of this weekly basal insulin is a new treatment solution option for diabetes patients who previously relied solely on daily basal insulin. The US FDA approval is based on the results of the ONWARDS phase 3a programme in type-2 diabetes for once-weekly injection, which is a clinical trial programme consisting of four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, and used in combination with mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists.
The clinical trial program compared weekly basal insulin with daily insulin, with results showing similar reductions in HbA1c levels in adults with type 2 diabetes. In addition, the safety profile of weekly basal insulin was overall consistent with daily basal insulin.
"Novo Nordisk's move to provide weekly basal insulin reflects our ongoing commitment to advancing healthcare innovation and strengthening support for people with diabetes. As some pharmaceutical companies have begun to withdraw from the insulin category, we have reaffirmed our commitment to supporting innovation, access, and supply for millions of patients who rely on insulin every day," said Mike Doustdar, President and CEO of Novo Nordisk, Monday, May 25.
In Indonesia, more than 20 million adults live with diabetes. However, awareness and adherence to diabetes patient treatment are still a challenge.
A study found that 43.4 percent of respondents, who were type 2 diabetes patients, stated that their compliance barriers came from feeling burdened by having to undergo treatment every day, while another 28.4 percent of respondents admitted that they often forgot to undergo treatment. Thus, weekly basal insulin can be a relevant alternative to simplify therapy and support diabetes treatment compliance.
For more than 20 years, Novo Nordisk has continued to be committed to supporting Indonesia in addressing the challenges of diabetes, as one of the national health crises. In Indonesia, Novo Nordisk has introduced innovative insulin therapy formulations, as well as GLP-1 therapy for different indications, namely for the treatment of type 2 diabetes and for the treatment of obesity.
Novo Nordisk urges the public to consult a doctor for more information, including before changing doses or starting treatment.
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