First Drug That Can Delay Onset of Type 1 Diabetes Gets FDA Approval After Multiple Regulatory Hurdles

  • The FDA approved Provention Bio Inc’s PRVB 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. 
  • Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days. 
  • Tzield’s safety and efficacy were evaluated in a 76-patient trial. The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. 
  • The therapy narrowly passed the vote at an FDA advisory committee meeting in May last year amid questions about the small study size and more
  • The FDA hit teplizumab with a complete response letter, rejecting the application, in June last year.
  • After resubmitting the marketing application, the FDA extended the review period by three months.
  • In October, the company announced a co-promotion agreement for the U.S. launch of Tzield for the delay in the onset of clinical T1D in at-risk individuals with Sanofi SA SNY
  • Teplizumab was previously developed by MacroGenics Inc MGNX, which PRVB licensed in May 2018.
  • Under the agreement, MacroGenics is entitled to receive $60 million upon FDA approval.
  • Price Action: PRVB shares are 4.37% higher at $8.60 premarket on the last check Friday.
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