Provention Bio’s TZIELD Approved as First Treatment to Delay Onset of T1D

Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, received FDA approval for its Biologics License Application (BLA) for TZIELD (teplizumab-mzwv), an anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients 8 years and older with stage 2 T1D.  
 
Tzield binds to certain immune system cells to delay 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 was evaluated in a randomized, double-blind, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. Patients randomly received Tzield or a placebo once daily via intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis. 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 mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.
 
The most common adverse reactions (>10%) that occurred during treatment were lymphopenia (73% TZIELD, 6% Placebo), rash (TZIELD 36%, Placebo 0%), leukopenia (TZIELD 21%, Placebo 0%) and headache (TZIELD 11%, Placebo 6%).    
 
“This is a historic occasion for the T1D community and a paradigm shifting breakthrough for individuals aged 8 years and older with Stage 2 T1D who now have a therapy approved by the FDA to delay the onset of Stage 3 disease. It cannot be emphasized enough how precious a delay in the onset of Stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications and risks associated with Stage 3 disease,” said Ashleigh Palmer, Co-Founder and CEO of Provention Bio. “We would especially like to acknowledge and thank all the researchers, scientists, developers, and investigators, especially TrialNet and NIDDK; all the clinical trial participants and their families; the FDA and its reviewers; and JDRF and other patient advocacy groups and champions who have, over more than two decades, tirelessly and selflessly contributed to the development and approval of this first and only therapy to address the underlying autoimmunity of T1D, thereby fundamentally changing the course of the disease rather than just treating its symptoms.”