US Food and Drug Administration (FDA) approved medicines of Drug company Sanofi’s drug Tzield has to treat type 1 diabetes in children.
The FDA is also currently reviewing the use of Tzield to approve it for patients 8 years of age or older who have recently been diagnosed with stage 3 type 1 diabetes, to prevent the progression of the disease.
The company recently received approval for an additional biologics license application for Tzield, under which the drug can be used to delay the onset of stage 3 type 1 diabetes in children.
This development is historic in that it is the first time that an approved therapy has been made available for children with stage 2 type 1 diabetes that directly targets the autoimmune process behind the disease, which may provide some comfort to patients and their families.
The decision was made based on one-year data from the PETITE-T1D Phase IV study, which evaluated the safety and pharmacokinetics of Zelda in children under 8 years of age.
Zelda is currently approved for use in Brazil, Canada, China, the European Union, Kuwait, Saudi Arabia, the United Arab Emirates, and the United Kingdom. The FDA had previously granted the drug Breakthrough Therapy and Orphan Drug designations.
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