First FDA-approved drug to delay Type 1 diabetes now available in … – Orlando Sentinel

Central Florida residents now have access to the first-ever treatment to delay Type 1 diabetes.
In November, the U.S. Food and Drug Administration approved Provention Bio and Sanofi’s monoclonal antibody teplizumab — marketed as Tzield, for prediabetic adults and children over 8. A clinical trial found this drug prevented the onset of this disease in prediabetic people for an average of about two years.
AdventHealth Orlando helped screen patients for the clinical trial that led to this drug’s approval and is now one of a handful of hospitals approved to distribute it. On Jan. 11, medical director of Pediatric Endocrinology and Diabetes at AdventHealth for Children, Dr. Konda Reddy began administering the 14-day course of infusions to his first patient.
“[It] cannot be emphasized enough how precious to delay the diagnosis of Type 1 diabetes can be from a family and patient perspective,” Reddy said. “More time to live without insulin shots, more time to live without finger sticks, more time to live without the prescribed diabetes diet. This is a gift.”
Type 1 diabetes, an autoimmune disease, causes a person’s immune system to destroy insulin-producing cells, elevating blood glucose to dangerous levels. The nearly 2 million U.S. kids and adults with Type 1 diabetes need to be injected with insulin daily, or they will die.
Tzield comes with caveats: the drug’s manufacturer has priced it at nearly $194,000 for a full course of treatment, though insured patients’ out-of-pocket costs will be less, depending on their coverage.
The two-week course of treatment temporarily compromises the immune system and can lead to serious infections, organ dysfunction, decreased levels of certain white blood cells, rashes and headaches. This is why the study only allowed participants at high risk.
Dr. Anna Casu, an associate investigator in Type 1 diabetes research at the AdventHealth Translational Research Institute, said delaying the onset of diabetes for even just a few years is worth the risk for people who are going to develop it eventually.
“Any year with high blood glucose levels is a year of building chronic complications of the disease,” said Casu, who helped screen some participants for this study. “[Delaying] it contributes to preventing the burden of chronic complications in the long run.”
Diabetes — itself the eighth-leading cause of death in the U.S. — is also the leading cause of kidney failure, lower-limb amputations and adult blindness. It also leads to heart disease, the United States’ No. 1 killer.
It’s expensive, too: the RAND Corp. estimated that in 2018, the average vial of insulin cost nearly $100 out-of-pocket in the U.S. Most Type 1 diabetics need one to three per month.
Casu noted that this medication will not work on Type 2 diabetes, which accounts for 95% of U.S. diabetes cases. Type 2 occurs when a person’s cells don’t properly respond to insulin. Unlike Type 1, it can be delayed or prevented with lifestyle changes.
Screening, which involves analysis of a blood sample, is hugely helpful to Type 1 diabetics’ outcomes, Casu said.
Without early screening, people, particularly kids, don’t get diagnosed with Type 1 diabetes until insulin reaches critically low levels and a life-threatening reaction called ketoacidosis lands them in the hospital, she added.
Since Type 1 is largely genetic, everyone with a close family member who has Type 1 diabetes should be screened, Casu said.
Casu, herself a Type 1 diabetic, has pushed several of her family members to get screened.
A Tzield prescription is not available without a screening, which is offered at many doctors’ offices as well as via online order. At-home blood tests for signs of Type 1 diabetes can be ordered from Enable Biosciences for $89, or $10 with an opt-in subsidy for people who need financial assistance. The website offers resources for finding Tzield if the test indicates eligibility.
“People say, ‘Hey, yeah, I know that my kid is at risk. There’s nothing I can do, so I don’t want to [screen them,]” she said. “It’s important to push people to screen for this disease now, especially those at high risk like the relatives of individuals with Type 1, children of people with Type 1, because there’s an option now.”
Casu added there are studies happening right now to determine whether it’s beneficial to screen everyone for Type 1 diabetes, regardless of family connection.
About 85% of Type 1 diagnoses are in families who don’t have a known history of the condition.
Ccatherman@orlandosentinel.com; @CECatherman Twitter
Copyright © 2023, Orlando Sentinel
Copyright © 2023, Orlando Sentinel

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