Sanofi has recently got the US Food and Drug Administration (FDA) for a supplemental biologic licence application for Tzield, allowing its use to delay stage 3 type 1 diabetes (T1D) onset in children.
It marks the first time in history that kids suffering from stage 2 Type 2 diabetes received an approved therapy that addresses the underlying autoimmunity behind the disease, letting them to finally take a sigh of relief.
This decision is supported by one-year data from the PETITE-T1D Phase IV study, which assessed the safety and pharmacokinetics of Tzield in children under eight years old.
Moreover, the FDA is currently reviewing Tzield for use in patients eight years and over recently diagnosed with stage 3 T1D to prevent the progression of disease.
The therapy is currently approved in Brazil, Canada, China, the European Union (EU), Kuwait, Saudi Arabia, the United Arab Emirates, and the UK.
Earlier, the FDA granted Tzield breakthrough therapy and orphan drug designations.
The PETITE-TID Phase IV trial is a single-arm, non-randomised, multi-centre study involving 23 participants. It examined Tzield’s safety and pharmacokinetics in children under eight years with stage 2 T1D.
Participants received daily intravenous infusions for 14 days. The total study duration, including screening, treatment, and follow up, may last up to 26 months.
Sanofi development global head Christopher Corsico said: “The autoimmune attack driving this disease often begins early in life, and the burden that autoimmune T1D poses in this very young population and their families is significant.”
“This approval underscores the importance of targeting the immune system early in autoimmune type 1 diabetes, aiming to impact its natural progression by delaying the loss of insulin production in the pancreas,” Corsico added.
