Development of the First Drug Capable of Delaying Type 1 Diabetes Is Now Approved by the FDA
Type 1 diabetes is an insulin-dependent diabetes which is chronic and not curable at this time. A person can acquire Type 1 diabetes through genetics and viral infection. Human Enteroviruses (HEVs) is a group of viruses capable of intruding the gut due to poor hygiene and sanitation. The disease is usually diagnosed in children and young adults. Once the body has acquired this type of diabetes, the immune system will be wired to kill beta cells, because they are identified as an intruder. For this reason, insulin production is badly impacted, which leads to abnormal levels of blood sugar in the body. Complications in certain body parts will follow if not given proper medication.
According to a study, the world had a record of 8.4 million Type 1 diabetes cases in 2021. It is predicted that the cases will double in 2040 and may increase for about 17.4 million more diabetes patients. Due to the rising numbers, pharmaceutical scientists are working on effective drugs that will resolve the situation. As a result of continuous research, professionals have successfully developed a drug that was recently approved by the FDA. Based on reports, the drug called Tzield can delay the onset of Type 1 diabetes at stage 3 for adults. As for children, the medication works on ages 8 and above in stage 2 Type 1 diabetes.
Tzield was approved with the help of Priority Review and Breakthrough Therapy. The drug containing teplizumab-mzwv was brought into further development by the biopharmaceutical company ProventionBio. If the medication is taken, Tzield is said to have the ability to deactivate immune cells that attack the pancreatic islet cells. The newly approved drug contains a humanized monoclonal antibody that attaches to the CD3 Marker molecules found on the immune cell’s exterior. Once it binds to the T cell receptor-CD3, it will weaken the signaling pathway that triggers the immune cells. Therefore, insulin production will not be affected, and the body will function normally.
Before Tzield was approved, the team of pharmaceutical scientists underwent several observations to test its effectiveness. The procedure involved 78 TD1 patients randomized into separate control groups. Some received the Tzield, while others were provided with a placebo. Information about how long since the patient entered stage 3 Type 1 diabetes was considered a variable for the study. After a follow-up of two years, the results showed that 45% of patients who consumed Tzield entered stage 3. Meanwhile, 72% of patients in the placebo group developed stage 3 within the same time frame.
The reason for the drug’s approval was that it proved how it delayed TD1 progress. Patients in the placebo group entered stage 3 TD1 after 25 months, while there was an apparent delay with those under Tzield. The drug doubled the gap between randomization and the start of stage 3. Although a breakthrough, there are still existing side effects of consuming Tzield. The medication can cause:
- Decrease in lymphocytes
- Triggers the production of inflammatory chemicals called cytokines.
If the body receives an overwhelming number of cytokines, it can lead to a syndrome called Cytokine Release Syndrome. It’s a health condition that leads to systemic hyper-inflammation and organ malfunction. The patient must be prescribed medication regulating cytokine release before taking Tzield. In addition, hypersensitivity can be a side effect as well. Necessary vaccinations advised for the person’s age must be discussed with your physician. Due to these side effects, guardians are highly recommended to monitor patients after injecting the drug. It is also important to remember that Tzield can only be injected once a day for two weeks.
