The world's first! FDA approves new drug for type 1 diabetes

On November 17, the FDA announced the approval of Provention Bio's research CD3 monoclonal antibody Teplizumab (trade name: Tzield), which is used to delay or prevent clinical type 1 diabetes in adults and people over 8 years old. Teplizumab is the world's first drug that can delay the onset of type 1 diabetes.

From: FDA official website

Teplizumab is a monoclonal antibody targeting the CD3 antigen on the surface of T cells. By binding to CD3 on the surface of effector T cells, it inhibits the attack of T cells on islet β cells, thereby protecting the islet β cells from destruction.

The approval was based on the results of a randomized, double-blind, placebo-controlled trial that included 76 subjects and showed that during a median follow-up of 51 months, 44 subjects treated with Teplizumab Forty-five percent of the patients were eventually diagnosed with stage 3 T1D, compared with 72 percent of the 32 patients who received placebo. And the time to disease progression was about 50 months in the Teplizumab treatment group, compared with 25 months in the control group.

However, the development of this product has not been smooth, and pharmaceutical transactions are also very frequent.

Teplizumab was originally developed by MacroGenics. Lilly introduced the product in 2007 with an upfront payment of $41 million, but stopped the deal after a later Phase III clinical trial failed to meet the primary endpoint.

In 2018, Provention Bio took a fancy to Teplizumab, acquiring the product from MacroGenics. Teplizumab has since been advanced to the marketing stage. Although it was previously rejected by the FDA due to pharmacokinetic comparability issues, it has achieved good results in the end.

In addition, in October 2022, Provention bio and Sanofi reached a cooperation to pave the way for the commercialization of Teplizumab in advance.