The Diabetes type 1 It occurs most often in children and young adults, but it can appear at any age. In the United States, the drug regulatory authority, the Food and Drug Administration (FDA), first approved a drug that can delay the progression of this type of diabetes, a disease that manifests itself because the pancreas does not produce insulin.
This is the injection of the drug teplizumab. May delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older who currently have stage 2 type 1 diabetes, reported the FDA. It does not prevent or cure the disease.
After doing a priority review, the regulatory agency approved it as an innovative treatment. The approval of a first-in-class therapy “adds an important new treatment option for certain at-risk patients,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity at the Center for Drug Evaluation and Research. of the regulatory agency.
“The potential of the drug to delay the clinical diagnosis of type 1 diabetes may provide patients with months or years without disease burden”, he added in a statement.
Type 1 diabetes is a disease that occurs when the immune system attacks and destroys the cells that make insulin. People diagnosed with type 1 diabetes have a spike in glucose that requires insulin injections or the use of an insulin pump to survive and must check their blood sugar levels regularly throughout the day.
Los symptom Type 1 diabetes symptoms may include: being very thirsty, urinating frequently, feeling very hungry or tired, unexplained weight loss, sores that are slow to heal, dry and itchy skin, loss of sensation or tingling in the feet, and blurry vision.
A person is at increased risk of type 1 diabetes if they have a parent, brother, or sister with type 1 diabetes, although most patients with type 1 diabetes do not have a family history.
When given to a person with diabetes, the approved drug binds to certain cells of the immune system and slows the progression to stage 3 type 1 diabetes. It can turn off immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.
The drug is administered by intravenous infusion once a day for 14 consecutive days. The regulatory authority considered a randomized, double-blind clinical trial that evaluated the safety and efficacy of the drug based on events and placebo-controlled in 76 patients with stage 2 type 1 diabetes.
In the study, patients were randomly given either the drug or a placebo once daily by intravenous infusion for 14 days. The primary measure of effectiveness was the time from randomization to development of the diagnosis of stage 3 type 1 diabetes.
Results of the study showed that during a median follow-up of 51 months, 45% of the 44 patients who received the drug were subsequently diagnosed with stage 3 type 1 diabetes, compared with 72% of the 32 patients who received a placebo.
The median time from randomization to diagnosis of stage 3 type 1 diabetes was 50 months for patients who received the drug and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.
The most common side effects of the medication include reduced levels of certain white blood cells, rash, and headache. Its use comes with warnings and precautions, including premedication and management of cytokine release syndrome symptoms; the risk of serious infections; and decreased levels of a type of white blood cell called lymphocytes; the risk of hypersensitivity reactions.
It is also mentioned that all age appropriate vaccinations should be given before starting the injections of the drug. Simultaneous use of live, inactivated and mRNA vaccines with the medicinal product should be avoided.
The teplizumab It was developed by the company Provention Bio, which will partner with Sanofi to market it in the United States under the Tzield brand. In a call for investors, according to the newspaper The New York Times, the Provention company said the drug would cost $13,850 a vial or $193,900 for a 14-day treatment. At the moment, it is not available in Latin American countries, such as Argentina.