teplizumab
Coverage of teplizumab in the Nexus archive.
- Drug that delays onset of type 1 diabetes approved in England and Wales
The drug teplizumab, which delays the onset of type 1 diabetes for up to three years, has been approved for NHS use in England and Wales. It marks the first treatment of its kind and is described as a major breakthrough in diabetes care.
- STAT+: FDA approves Sanofi diabetes drug for children with stage 3 diabetes
The FDA approved Sanofi's teplizumab for children aged 8 and older with stage 3 diabetes. The drug underwent a speedy review program but the agency missed its decision deadline of April 21. Sanofi requested to withdraw the drug from the program after Tracy Beth Høeg, a former top drug regulator, disagreed with a staff approval decision.
- STAT+: Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review
Sanofi has asked the FDA to pull its type 1 diabetes drug, teplizumab, out of a speedy drug review program after a dispute over the approval decision. The agency missed its goal date of April 21 to deliver a decision to Sanofi. The dispute involved acting Center for Drug Evaluation and Research director Tracy Beth Høeg.