Written by: Sophia Schiro
Edited by: Kaitlin Lemke
Edited by: Kaitlin Lemke
Teplizumab’s recent approval by the Food and Drug Administration (FDA) is cause for celebration, as it is the first treatment to delay the onset of Type 1 diabetes, as well as the first to change the course of the disease since insulin’s discovery in 1922 (Backman and Macmillan 2022).
Currently, over 8.7% of the U.S. population is affected by diabetes. This widely known chronic health condition is only increasing in prevalence, with the Center for Disease Control (CDC) reporting a 30% increase in Type 1 diabetes diagnoses and a sharp growth in cases among U.S. adolescents in recent years (Mulvey 2020).
Type 1 diabetes is an autoimmune disorder in which the body destroys beta cells of the pancreas. These cells normally function to produce insulin, a hormone that works to lower the amount of glucose in your bloodstream and regulate the body’s metabolism of carbohydrates. With the loss of these cells, individuals with the disease have little to no insulin production. This results in high blood sugar — they have no way to get rid of excess glucose in the bloodstream. Symptoms caused by this phenomenon include increased thirst, excessive urine, hunger, and fatigue.
The condition is usually treated with diet regulation, exercise, and, most importantly, insulin therapy; insulin therapy consists of the injection of insulin through pumps, shots, or pens into the body in order to replace what the body would produce normally. Unfortunately, in the past ten years, the cost of insulin has increased by 14% annually (Hayes and Farmer 2020), contributing to diabetes’ recognition as the most expensive chronic condition in the United States – the Health Care Cost Institute found that the average insulin user spends nearly $6,000 annually as of 2020 (Farmer and Hayes 2020). While this is very costly, the expense of the disease lies not only in the price of insulin, but also in the time-consuming nature of managing symptoms. Type 1 diabetics deal with constant insulin therapy and diet management over the course of this lifelong condition, often beginning in adolescence. Ultimately, the costs of managing diabetes over the course of one’s life are becoming unsustainable. Thus, there is an increasing necessity for novel treatments and cures now more than ever.
Fortunately, on November 17, 2022, the FDA approved Teplizumab, a drug that could greatly alter the treatment of the disease. The drug is produced by ProventionBio, who have partnered with Sanofi to market the drug under the brand name “TZIELD.” The drug is a monoclonal antibody that modifies T-cells, which means that the drug changes the normal immune cell activity. Specifically, immune cell activity will be decreased to prevent the attacking of insulin-producing pancreas cells during the pre-diabetic state. Thus, it will take longer for the cells that produce insulin to be destroyed, prolonging the pancreas’ ability to create insulin. Protecting this function has been found to postpone the median onset of the disease by two years or more. However, it should be noted that one participant even remained diabetes-free for eleven years after Teplizumab treatment (Hirsch 2023).
Eligible patients include adults and children older than eight years old who are currently in Stage 2 of Type 1 diabetes. Stage 2 is one step before disease diagnosis, characterized by the presence of diabetes-related antibodies and abnormal blood sugar levels, but without symptoms. The treatment involves fourteen days of a 30-minute Teplizumab infusion. Teplizumab currently costs $13,850 a vial, and with fourteen days of treatment, the total cost comes out to about $193,900 (Rodriguez 2022). With such a high price, it is evident that Teplizumab’s success among consumers will lie in its ability to be covered by insurance. Even so, its existence as a preventative treatment is revolutionary.
While the long-term effects of Teplizumab and its usage remain unknown, the treatment has been found to result in a decreased white blood cell count in some patients. Since these cells are important for the immune system, this side effect could increase the risk of developing severe diseases.
An important implication of this treatment is that the delayed onset of Type 1 diabetes could take patients to an age where they are better able to manage the disease. For example, a high schooler may be more equipped than a middle schooler to handle the demands of a chronic disease and its treatment. It can be very difficult to be constantly concerned about the food that is going into
your body and making sure to dose at the correct time – this is likely too overwhelming for young children to keep track of. Another benefit to a later onset of diabetes is that it reduces the amount of exposure to high blood sugar over time, which has been known to cause health complications such as kidney damage, nerve damage, heart disease, and stroke.
In addition, a report by the CDC found a recent increase in the prevalence of Type 1 diabetes, primarily in populations of African American and Hispanic children. Between 2002 and 2015, cases rose 19-20% in these groups, while they only increased about 14% in Caucasian children (Mulvey 2020). This disparity is due to less access to medical treatment, giving further reason to search for preventative treatments, while making them more accessible as well. If there is equitable access of Teplizumab via insurance, its usage would result in less prevalence of diabetes cases and less money spent on insulin overall, especially in communities where Type 1 diabetes is more common.
While two years of delayed onset may seem like an insignificant advance, Teplizumab’s existence as a therapy to change the course of the disease promises significant advantages, providing further momentum in the discovery of novel diabetes treatments. With FDA approval, we can be even more optimistic about future discoveries.
References
Backman I., Macmillan C. 2022. 3 things to know about Teplizumab, the new diabetes drug. Yale Medicine [Internet]. [cited February 21, 2023]. Available from: https://www.yalemedicine.org/news/teplizumab-new-diabetes-drug
Hayes, T., Farmer, J. 2020. Insulin cost and pricing trends. American Action Forum [Internet]. [cited February 36, 2023]. Available from:
https://www.americanactionforum.org/research/insulin-cost-and-pricing-trends/
Hirsch, J. 2023. FDA approves teplizumab: a milestone in type 1 diabetes. The Lancet Diabetes & Endocrinology, Volume 11, Issue 1, Page 18 [Internet]. [cited February 25, 2023]. Available from: https://doi.org/10.1016/S2213-8587(22)00351-5
Mulvey, A. 2020. More people being diagnosed with Type 1 Diabetes. Juvenile Diabetes Research Foundation [Internet]. [cited February 26, 2023]. Available from: https://www.jdrf.org/blog/2020/02/18/more-people-being-diagnosed-type-1-diabetes/
Rodriguez A. 2022. FDA approves first treatment that delays Type 1 diabetes. USA Today [Internet]. [cited February 21, 2023]. Available from: https://www.usatoday.com/story/news/health/2022/11/18/fda-approves-teplizumab-delays-onset diabetes/10721707002/
Currently, over 8.7% of the U.S. population is affected by diabetes. This widely known chronic health condition is only increasing in prevalence, with the Center for Disease Control (CDC) reporting a 30% increase in Type 1 diabetes diagnoses and a sharp growth in cases among U.S. adolescents in recent years (Mulvey 2020).
Type 1 diabetes is an autoimmune disorder in which the body destroys beta cells of the pancreas. These cells normally function to produce insulin, a hormone that works to lower the amount of glucose in your bloodstream and regulate the body’s metabolism of carbohydrates. With the loss of these cells, individuals with the disease have little to no insulin production. This results in high blood sugar — they have no way to get rid of excess glucose in the bloodstream. Symptoms caused by this phenomenon include increased thirst, excessive urine, hunger, and fatigue.
The condition is usually treated with diet regulation, exercise, and, most importantly, insulin therapy; insulin therapy consists of the injection of insulin through pumps, shots, or pens into the body in order to replace what the body would produce normally. Unfortunately, in the past ten years, the cost of insulin has increased by 14% annually (Hayes and Farmer 2020), contributing to diabetes’ recognition as the most expensive chronic condition in the United States – the Health Care Cost Institute found that the average insulin user spends nearly $6,000 annually as of 2020 (Farmer and Hayes 2020). While this is very costly, the expense of the disease lies not only in the price of insulin, but also in the time-consuming nature of managing symptoms. Type 1 diabetics deal with constant insulin therapy and diet management over the course of this lifelong condition, often beginning in adolescence. Ultimately, the costs of managing diabetes over the course of one’s life are becoming unsustainable. Thus, there is an increasing necessity for novel treatments and cures now more than ever.
Fortunately, on November 17, 2022, the FDA approved Teplizumab, a drug that could greatly alter the treatment of the disease. The drug is produced by ProventionBio, who have partnered with Sanofi to market the drug under the brand name “TZIELD.” The drug is a monoclonal antibody that modifies T-cells, which means that the drug changes the normal immune cell activity. Specifically, immune cell activity will be decreased to prevent the attacking of insulin-producing pancreas cells during the pre-diabetic state. Thus, it will take longer for the cells that produce insulin to be destroyed, prolonging the pancreas’ ability to create insulin. Protecting this function has been found to postpone the median onset of the disease by two years or more. However, it should be noted that one participant even remained diabetes-free for eleven years after Teplizumab treatment (Hirsch 2023).
Eligible patients include adults and children older than eight years old who are currently in Stage 2 of Type 1 diabetes. Stage 2 is one step before disease diagnosis, characterized by the presence of diabetes-related antibodies and abnormal blood sugar levels, but without symptoms. The treatment involves fourteen days of a 30-minute Teplizumab infusion. Teplizumab currently costs $13,850 a vial, and with fourteen days of treatment, the total cost comes out to about $193,900 (Rodriguez 2022). With such a high price, it is evident that Teplizumab’s success among consumers will lie in its ability to be covered by insurance. Even so, its existence as a preventative treatment is revolutionary.
While the long-term effects of Teplizumab and its usage remain unknown, the treatment has been found to result in a decreased white blood cell count in some patients. Since these cells are important for the immune system, this side effect could increase the risk of developing severe diseases.
An important implication of this treatment is that the delayed onset of Type 1 diabetes could take patients to an age where they are better able to manage the disease. For example, a high schooler may be more equipped than a middle schooler to handle the demands of a chronic disease and its treatment. It can be very difficult to be constantly concerned about the food that is going into
your body and making sure to dose at the correct time – this is likely too overwhelming for young children to keep track of. Another benefit to a later onset of diabetes is that it reduces the amount of exposure to high blood sugar over time, which has been known to cause health complications such as kidney damage, nerve damage, heart disease, and stroke.
In addition, a report by the CDC found a recent increase in the prevalence of Type 1 diabetes, primarily in populations of African American and Hispanic children. Between 2002 and 2015, cases rose 19-20% in these groups, while they only increased about 14% in Caucasian children (Mulvey 2020). This disparity is due to less access to medical treatment, giving further reason to search for preventative treatments, while making them more accessible as well. If there is equitable access of Teplizumab via insurance, its usage would result in less prevalence of diabetes cases and less money spent on insulin overall, especially in communities where Type 1 diabetes is more common.
While two years of delayed onset may seem like an insignificant advance, Teplizumab’s existence as a therapy to change the course of the disease promises significant advantages, providing further momentum in the discovery of novel diabetes treatments. With FDA approval, we can be even more optimistic about future discoveries.
References
Backman I., Macmillan C. 2022. 3 things to know about Teplizumab, the new diabetes drug. Yale Medicine [Internet]. [cited February 21, 2023]. Available from: https://www.yalemedicine.org/news/teplizumab-new-diabetes-drug
Hayes, T., Farmer, J. 2020. Insulin cost and pricing trends. American Action Forum [Internet]. [cited February 36, 2023]. Available from:
https://www.americanactionforum.org/research/insulin-cost-and-pricing-trends/
Hirsch, J. 2023. FDA approves teplizumab: a milestone in type 1 diabetes. The Lancet Diabetes & Endocrinology, Volume 11, Issue 1, Page 18 [Internet]. [cited February 25, 2023]. Available from: https://doi.org/10.1016/S2213-8587(22)00351-5
Mulvey, A. 2020. More people being diagnosed with Type 1 Diabetes. Juvenile Diabetes Research Foundation [Internet]. [cited February 26, 2023]. Available from: https://www.jdrf.org/blog/2020/02/18/more-people-being-diagnosed-type-1-diabetes/
Rodriguez A. 2022. FDA approves first treatment that delays Type 1 diabetes. USA Today [Internet]. [cited February 21, 2023]. Available from: https://www.usatoday.com/story/news/health/2022/11/18/fda-approves-teplizumab-delays-onset diabetes/10721707002/
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