FDA Approves First Drug for Delaying Type 1 Diabetes – What You Should Know

Recently, the United States Food and Drug Administration granted approval for Tzield (teplizumab-mzwv) injection: a groundbreaking treatment intended to obstruct the progression of stage 2 type 1 diabetes into its more serious form in adults as well as pediatric patients who are 8 years or older.

John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research said, “the drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.” 

Type 1 diabetes is an autoimmune disease in which the cells that produce insulin, a hormone responsible for regulating blood sugar levels, are destroyed. This can lead to severe health issues such as heart and kidney diseases, nerve damage, blindness, and even death if left untreated. While there have been treatments to manage symptoms and reduce blood sugar levels, Tzield is the first drug specifically designed to prevent or delay the onset of type 1 diabetes.

Tzield delays progression to stage 3 type 1 diabetes by binding to certain immune system cells. Tzield has the potential to deactivate destructive immune cells that damage insulin-producing cells, while growing the amount of helpful moderating ones. Intravenous infusions must be received daily for two weeks consecutively in order to administer Tzield properly.

Tzield’s safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients were randomly assigned to receive Tzield or a placebo intravenously once daily for 14 days. To determine efficacy, time from randomization to diagnosis of stage 3 type 1 diabetes was used as the primary measure.

After a follow-up period of 51 months, the trial data indicated that 45% of 44 patients receiving Tzield were diagnosed with stage 3 type 1 diabetes, compared to 72% in those given a placebo. On average, 50 months elapsed for the group taking Tzield before diagnosis and only 25 months passed in the control group—a huge difference exhibiting significant delay from developing stage 3 type 1 diabetes.

Tzield may cause decreased levels of white blood cells, rash, and headache. It is important to be aware of the warnings and precautions associated with this medication—such as premedicating for cytokine release syndrome symptoms, monitoring for infection risks, managing lymphocyte levels closely, preventing hypersensitivity reactions through appropriate use, making sure all age-appropriate vaccinations are administered before taking Tzield treatments begin; additionally ensuring that live vaccines or inactivated/mRNA vaccines are not taken alongside Tzield.

About the manufacturer

Provention Bio, Inc., is a revolutionary biopharmaceutical leader devoted to halting and preventing immune-mediated illnesses. When speaking of just how important this breakthrough is, Ashleigh Palmer, Co-Founder and CEO of Provention Bio said, “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.” 

Provention Bio has unveiled COMPASS, a patient support system with a dedicated team of professionals available to answer queries and provide assistance on coverage, reimbursement and accessibility for individuals prescribed TZIELD.