The medical industry has been dedicated not just to healing the sick but finding ways to avoid being ill in the first place. They have made strides once again, as the FDA approves the first drug that slows down the development of Type 1 diabetes (T1D). The intravenous medication is called Teplizumab (Tzield) according to Interesting Engineering.
The First Drug in Medical History to Delay T1D
The drug is said to delay the onset of Type 1 diabetes, which could be beneficial for adults with stage three T1D, as well as children at eight years or older at stage two. Dr. John Sharretts, the Director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research, said that it provides patients with months to years without the struggles of the disease.
The pharmaceutical company responsible for the drug is called Provention Bio. "Tzield" will bind certain cells in the immune system. Specifically, it will render immune cells that attack insulin-producing cells, inactive. Upon the administration of the drug, the proportion of cells that moderate the immune system's response would increase, according to reports.
The agency has already tested the effectiveness of the drug, via a placebo-controlled trial. 76 stage two T1D patients were injected with either placebo or Tzield, which was stretched out for 14 days. Researchers at the FDA observed the progression between the time of the trial and the development of stage three T1D.
The development spanned 51 months with 44 patients who received the drug. 45% of the patient who received Tzield progressed to stage three T1D, as well as 72% of patients who were injected with a placebo. Patients who received the drugs reached stage three in 50 months, while those who got a placebo took only 25 months, which proves that the drug works.
Precautions for Patients Who Will Use Tzield
According to the drug's website, there are warnings and precautions that patients should heed, should they decide to use the drug to delay Type 1 diabetes. Like all medications, the drug should be administered with caution, regarding side effects, and the previous and future medications that will be taken.
Cytokine Release Syndrome (CRS) occurred in patients treated with the drug, which persisted for 28 days after the last intravenous infusion. Before the Tzield treatment, patients should pre-medicate with antipyretics, antihistamines, and/or antiemetics. They should also medicate if symptoms appear again during treatment. In severe cases, the use of Tzield should be postponed for a day or two, or be stopped entirely.
Patients with active infections both serious and chronic are recommended not to take the drug. Localized skin infections may be an exception. The receiver of the drugs should be monitored for said infections during and after administration. Should an infection develop, they should stop the medication using Tzield.
Doctors should also watch for the patient's white blood cell counts during treatment, as most Tzield patients experienced Lymphopenia. Although, without interruption in the two-week treatment course, signs of recovery with lymphocyte cells were seen after five days. Values have also returned to normal within two weeks after administration.
Patients also experienced hypersensitivity reactions. Serum sickness, angioedema, urticaria, rash, vomiting, and bronchospasm were among said reactions. It is advised to stop the treatment immediately once these side effects occur.
