Islamabad (Health Desk) The drug “Zild”, developed by pharmaceutical company Sanofi, has received approval from the US Food and Drug Administration (FDA) for the treatment of Type 1 diabetes in children.
The US regulator is also currently reviewing expanded use of the drug for children aged eight years or older who have recently been diagnosed with Stage 3 Type 1 diabetes, with the aim of slowing or preventing disease progression.
The company has also recently received an additional Biologics License, allowing Zild to be used in delaying the onset of Stage 3 Type 1 diabetes in children.
Experts say this development is significant as it represents the first approved therapy for children with Stage 2 Type 1 diabetes that directly targets the autoimmune system responsible for the disease.
The approval was based on one-year Phase 4 data from the PETITE-T1D trial, which evaluated the safety and effectiveness of the drug in children under eight years of age.
Zild has already been approved for use in Brazil, Canada, China, the European Union, Kuwait, Saudi Arabia, the United Arab Emirates, and the United Kingdom, while the FDA had previously granted it Breakthrough Therapy and Orphan Drug designations.