First-of-its-kind Type 1 diabetes drug wins FDA approval

Provention Bio's teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen.

Tzield is an antibody that was initially created by MacroGenics that targets a protein called CD3 to control the immune system. The medication has been under testing for years, moving from MacroGenics to Eli Lilly in 2007 and then returning to MacroGenics in 2010 following the failure of a Phase 3 research.

Provention, a biotechnology company based in New Jersey, faithfully staked its future on the drug's ability to delay the full onset of Type 1 diabetes after acquiring the drug's rights in 2018.

Provention attempted to compile the necessary data to address the FDA's concern after the medicine was rejected by the agency last year. A "bridging study" looking at the effects of the medication on the body was partially responsible for the rejection.