Provention Bio received FDA approval for Tzield.
A diabetes type 1 treatment medication has been approved by the US FDA. For adults and paediatric patients 8 years of age and older who currently have stage 2 type 1 diabetes, the U.S. Food and Drug Administration has approved Tzield (teplizumab-mzwv) injectable to prevent the formation of stage 3 type 1 diabetes.
According to John Sharretts, M.D., of the FDA’s Center for Drug Evaluation and Research, the clearance of a first-in-class medicine adds a significant new treatment option for some at-risk patients.
Patients may experience months or years without the effects of the disease thanks to the drug’s capacity to delay the clinical diagnosis of type 1 diabetes.
How does the drug work
When the immune system targets and kills the cells that create insulin, type 1 diabetes develops.
Individuals who have been diagnosed with type 1 diabetes must monitor their blood sugar levels frequently throughout the day and must administer insulin shots or wear an insulin pump to survive.
Although type 1 diabetes can manifest at any age, it is typically detected in children and young people.
Although the majority of people with type 1 diabetes do not have a family history, having a parent, brother, or sister with the disease increases a person’s risk.
Tzield attaches to specific immune system cells and prevents type 1 diabetes from progressing to stage 3. It could inhibit the immune cells that target the cells that make insulin while boosting the number of cells that assist control the immunological response. Also, it is infused intravenously once each day for 14 days straight.
A randomised, double-blind, event-driven, placebo-controlled trial including 76 patients with stage 2 type 1 diabetes was conducted to assess the safety and effectiveness of Tzield. In the trial, subjects randomly administered Tzield or a placebo once day by intravenous infusion for 14 days. The interval between randomization and the onset of a stage 3 type 1 diabetes diagnosis served as the key indicator of effectiveness.
According to the trial findings, stage 3 type 1 diabetes was later detected in 45% of the 44 individuals who got Tzield, compared to 72% of the 32 patients who received a placebo after a median follow-up of 51 months. For patients who got Tzield, the median time from randomization to stage 3 type 1 diabetes diagnosis was 50 months, compared to 25 months for participants who received a placebo.
This represents a statistically significant delay in the development of stage 3 type 1 diabetes.
Drawbacks of the new drug
Tzield’s most frequent adverse reactions are rash, headache, and decreased levels of certain white blood cells.
The use of Tzield is accompanied by warnings and precautions. It includes the need to administer all age-appropriate vaccinations prior to starting Tzield. Additionally, avoid using live, inactivated, and mRNA vaccines concurrently with Tzield.
Other risks and side effects include the need to premedicate and monitor for symptoms of Cytokine Release Syndrome. Also, a risk of serious infections, decreased levels of a type of white blood cell called lymphocytes, risk of hypersensitivity reactions was found.
For this indication, Tzield was given the Priority Review and Breakthrough Treatment designations.