Drugs

FDA Expands Approval of Sanofi’s Tzield to Younger Children

FDA has approved an expanded indication for Sanofi’s Tzield (teplizumab), allowing its use in children as young as one year old to delay the onset of stage 3 Type 1 diabetes. The decision broadens Tzield’s previous U.S. approval, which covered patients aged eight and older with stage 2 disease. The therapy is now cleared for a significantly younger population diagnosed with stage 2 type 1 diabetes, a presymptomatic phase marked by autoimmune activity and abnormal blood glucose levels.

The approval was granted under a priority review and is supported by data from the Phase 4 PETITE-T1D study, which evaluated the drug’s safety and pharmacokinetics in children under eight, according to the company. The trial enrolled 23 participants and tested a regimen of once-daily intravenous infusions over 14 days.

Clinicians say the expanded indication addresses a critical window in disease progression. Younger children are often at higher risk of rapid onset of symptomatic diabetes, which can occur suddenly and requires lifelong insulin therapy.

Tzield is described as a CD3-directed monoclonal antibody designed to modulate the immune system’s attack on insulin-producing beta cells. Sanofi says the drug is also under FDA review for a potential additional use in patients aged eight and older who have been recently diagnosed with stage 3 disease, aiming to slow further progression.

Tzield was first approved in the U.S. in 2022 and has since gained authorizations in multiple regions, including Europe, Canada, and China, for delaying disease onset in older children and adults with stage 2 type 1 diabetes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome