Summary he decision was based on one-year data from the PETITE-T1D Phase IV study.
(Web Desk) - A drug developed by Sanofi, called Tzield, has received approval from the U.S. Food and Drug Administration for the treatment of children with Type 1 diabetes.
The FDA is also currently reviewing the use of Tzield to expand its approval for patients aged 8 years and older who have recently been diagnosed with stage 3 Type 1 diabetes, with the aim of slowing the progression of the disease.
The company, Sanofi, recently received approval for an additional biologics license application, which allows the drug to be used to delay the onset of stage 3 Type 1 diabetes in children.
This development is considered historic, as it marks the first time an approved therapy is available for children with stage 2 Type 1 diabetes that directly targets the underlying Autoimmune response responsible for the disease. This offers a degree of reassurance to patients and their families.
The decision was based on one-year data from the PETITE-T1D Phase IV study, which evaluated the safety and pharmacokinetics of Tzield in children under the age of 8.
Additionally, Tzield has already been approved for use in several regions, including Brazil, Canada, China, the European Union, Kuwait, Saudi Arabia, the United Arab Emirates, and the United Kingdom.
Previously, the FDA had granted the drug both “Breakthrough Therapy” and “Orphan Drug” designations.
