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US FDA Approves Groundbreaking Drug For Type 1 Diabetes

The FDA has approved a revolutionary immunotherapy drug to delay the development of type 1 diabetes. For the first time, experts say the drug can target the cause of the disease from the root rather than just treating its symptoms [1].

Tzield is developed by Provention Bio, a Pharma company in the US.

The newly-developed drug prevents the immune system from mistakenly attacking pancreatic cells that produce insulin by reprogramming the immune system. It is expected to pave the way for future approvals in other countries.

"Today's approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients," said the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research. "The drug's potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."

Diabetes mellitus or diabetes is a chronic condition that occurs when the pancreas doesn't produce enough insulin. Insulin helps regulate the blood sugar level by either absorbing the glucose in the blood or storing it in your body for future usage [2].

Known previously as juvenile diabetes or insulin-dependent diabetes, type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin. Insulin allows sugar (glucose) to enter cells to produce energy.

Type 1 diabetes can be caused by a variety of factors, including genetics and viruses. Although type 1 diabetes usually appears in childhood or adolescence, it can also develop in adults [3].

Till the introduction of the revolutionary drug, there have been no treatment options for type1 diabetes [4]. To date, treatment has been directed toward managing blood sugar levels through insulin, diet, and lifestyle changes.

Groundbreaking Drug For Type 1 Diabetes: Everything You Need To Know

Point 1: Tzield, also called teplizumab-mzwv, injection was recently approved by the U.S. Food and Drug Administration to delay the onset of stage 3 type 1 diabetes in adults and children age eight years and older who already have stage 2 diabetes [5].

Point 2: The effect of Tzield is that it binds to certain immune system cells and delays progression to type 1 diabetes stage 3. It also deactivates immune cells that attack insulin-producing cells, thereby increasing the proportion of immune cells that work to moderate immune response.

Point 3: For 14 consecutive days, Tzield must be administered as an intravenous infusion.

Point 4: The safety and efficacy of Tzield were evaluated in a randomized trial involving 76 patients with stage 2 type 1 diabetes.

Are There Any Side Effects To The New Drug For Type 1 Diabetes?

Some of the most common side effects of Tzield include headaches, rash, and decreased levels of certain white blood cells.

It is important to note that Tzield comes with warnings and precautions, including the necessity to premedicate and monitor for Cytokine Release Syndrome symptoms. Cytokine release syndrome (CRS) occurs when the immune system reacts abnormally to an infection or immunotherapy drug. Symptoms include fever, nausea, fatigue, and body aches. Prompt treatment is necessary to prevent symptoms from worsening [6].

The warnings also highlight the risk of serious infections, the decrease in white blood cells known as lymphocytes, the possibility of hypersensitivity reactions, the requirement to administer all age-appropriate vaccinations prior to starting Tzield, as well as avoiding the simultaneous use of live, inactivated, and mRNA vaccines with the drug.

On A Final Note...

The approval of the drug for type 1 diabetes is a massive win for the medical field, considering the years and years of research that has gone into developing an effective treatment for type 1 diabetes, and not just for the symptoms associated with the condition.

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