Recently, the US FDA announced that it has approved the marketing of the drug Tzield (teplizumab-mzwv) injection developed by Provention Bio, which is used to delay the delay in the treatment of adults with type 1 diabetes who are currently in stage 3 and in patients with type 1 diabetes who are 8 years old and older and in stage 2 sickness.

 

It is reported that this is a 'first-in-class' therapy that can delay the clinical progression of type 1 diabetes and provide patients with a period of months to years without the burden of the disease.

 

Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that produce insulin. People diagnosed with type 1 diabetes have elevated blood sugar, require insulin injections (or wear an insulin pump) to survive, and must regularly check blood sugar levels throughout the day. Although type 1 diabetes can appear at any age, it tends to occur more frequently in children and young adults. Although most people with type 1 diabetes have no family history, a person is at higher risk of developing type 1 diabetes if they have a parent, sibling, or sibling with type 1 diabetes.

 

Teplizumab is an anti-CD3 monoclonal antibody that works by binding to specific immune system cells. At the same time, the drug also inactivates immune cells that attack insulin-producing cells during treatment, increasing the number of cells that can regulate the immune response.

 

The approval of Teplizumab is based on a randomized, double-blind, event-driven, placebo-controlled trial. Seventy-six patients with type 1 diabetes participated in the trial and were randomly divided into two groups to receive placebo or teplizumab for a total of 14 days. The main measure of efficacy was from randomization to diagnosis of stage 3 type 1 diabetes time.

 

At a median follow-up of 51 months, 45 percent of the 44 patients treated with teplizumab were later diagnosed with stage 3 type 1 diabetes, compared with 72 percent of the 32 patients who received a placebo, the trial results showed . In addition, the time from randomization to diagnosis of stage 3 type 1 diabetes was 50 months in the teplizumab group and only 25 months in the placebo group. These data suggest that treatment with teplizumab can significantly delay the progression of type 1 diabetes.

 

Teplizumab was originally developed by Tolerance Therapeutics and University of California, San Francisco, and was licensed to MacroGenics in 2005.

 

In 2007, Lilly had its exclusive rights with an upfront payment of US$41 million, but in 2010, because a phase III trial of the drug failed to meet the primary endpoint, Lilly gave up further exploration. In 2018, Provention Bio acquired the drug from MacroGenics.

 

In 2019, Teplizumab achieved a milestone and was granted Breakthrough Therapy by the FDA. However, the subsequent listing process was not so smooth.

 

In July 2021, the FDA rejected Provention Bio's Teplizumab for the treatment of diabetes because the preliminary trials were conducted on healthy subjects and at low doses, and the research data were not sufficient.

 

In March 2022, Provention Bio reapplied to the FDA for Teplizumab as a drug for delaying high-risk diabetes type 1 diabetes. Today, Teplizumab has finally been approved by FDA.

 

It is worth mentioning that in October 2022, Provention Bio has joined forces with Sanofi to reach a cooperation agreement on the commercialization of teplizumab. Under the agreement, Provention Bio will retain all rights to the drug and handle all development, pharmacovigilance, manufacturing, quality and safety activities. Sanofi paid $20 million for exclusive global commercialization rights to teplizumab and, in addition, acquired $35 million of Provention common stock at a 40% premium following FDA approval.