The European Union Approves Drug That Slows the Progression of Type 1 Diabetes

The European Union Approves Drug That Slows the Progression of Type 1 Diabetes

The European Commission has approved the marketing of the drug “Tiselizumab,” designed to slow the progression of type 1 diabetes, within EU countries, as announced by its manufacturer, the French company Sanofi.

With this authorization, “Tiselizumab” becomes the first treatment that directly impacts the progression of type 1 diabetes to receive EU approval, according to a statement from the company.

The approval includes the use of the drug in adults and children over the age of eight, who are diagnosed with type 1 diabetes in its second stage.

This drug, administered via intravenous infusion, does not cure the disease, but it works to slow its progression by suppressing the autoimmune response. It is used after the diagnosis of the condition and prior to the onset of clinical symptoms, helping to delay the transition to the third stage that requires insulin injections to regulate blood sugar levels.

Sanofi stated that the European Commission’s decision was based on the positive results of the “TN-10” study, which demonstrated the ability of the monoclonal antibody “Tiselizumab” to delay the onset of clinical stage type 1 diabetes by nearly two years compared to a placebo.

The study found that the percentage of patients who remained in the second stage of the disease was about twice as high among those who received “Tiselizumab” compared to the group that received the placebo, with figures of 57 percent versus 28 percent.

“Tiselizumab” has previously received similar approvals in several countries, including the United States, the United Kingdom, China, Canada, Israel, Saudi Arabia, the United Arab Emirates, and Kuwait.