FDA approves first drug that can delay onset of type 1 diabetes

The US Food and Drug Administration late yesterday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes.

The FDA, which delayed making a decision on the drug in July, granted the Biologics License Application (BLA) approval of Tzield to Provention Bio (Nasdaq: PRVB), whose shares shot up 14.3% to $9.42 in pre-market trading this morning.

The FDA approval of Tzield marks the first and only immunomodulatory treatment shown to delay the onset of stage 3 T1D in patients ≥eight years old who currently have stage 2 T1D.