First Drug to Slow Type 1 Diabetes Approved by the FDA | smart news

Nearly two million Americans have Type 1 diabetes, according to the American Diabetes Association.
Photography by Javier Zayas via Getty Images

Last week, the Food and Drug Administration approved the first drug to delay the onset of type 1 diabetes.

In a clinical trial of 76 participants at high risk of diabetes, those who received the treatment were diagnosed an average of four years after the trial, compared with two years for those who received a placebo, according to NBC News. Berkeley Lovelace Jr. In one case, the drug delayed the onset of the disease by 11 years, the New York Times‘ Gina Kolata writes.

The drug is a breakthrough in diabetes treatment, experts say, but it won’t be cheap. It is administered intravenously on 14 consecutive days, by medpage todayin Nicole Lu. Each day’s treatment will cost $13,850 for a total of $193,900. The drug, called teplizumab, should be available by the end of the year.

The FDA has approved the treatment for people age 8 and older who are at high risk of developing type 1 diabetes, according to Medscape Medical NewsMiriam E. Tucker. It cannot be used to treat type 2 diabetes.

The approval is “really exciting” and “will turn the world of type 1 diabetes upside down,” said John Buse, a diabetes expert at the University of North Carolina who was not involved in the study. Schedules.

In most people, the pancreas releases insulin, a hormone that helps sugar in food travel from the bloodstream into the body’s cells, where it is used or stored for energy. But for people with type 1 diabetes, the pancreas produces very little or no insulin. This causes sugar to build up in the bloodstream, which can lead to health complications, according to the Centers for Disease Control and Prevention (CDC). The new drug is thought to stop the immune system from attacking insulin-producing cells in the pancreas.

Nearly two million people in the US have Type 1 diabetes. They must monitor their blood sugar daily and take insulin shots. The American Diabetes Association estimates that people with the condition spend more than $16,000 on medical expenses annually, and about $9,600 is for diabetes.

Type 1 diabetes usually develops in children, teens and young adults, but it can occur at any age, according to the CDC.

The researchers recruited study participants by examining immediate family members of people with type 1 diabetes, according to the Schedules. Study participants had the second stage of the disease, meaning they had antibodies indicative of diabetes and abnormal blood sugar levels, but no symptoms, he writes. usa todayin Adriana Rodrigues.

Treatment is not aimed at preventing people from developing the third and final stage of the disease, when symptoms develop. But by delaying its onset, the drug may give people additional time they don’t need to treat and monitor their diabetes, for example. usa today. Nearly all people with second-stage type 1 diabetes eventually develop the final clinical stage, and 75% develop it within five years, according to Medscape.

The most common side effects of the treatment were low white blood cell counts, headaches and rashes, according to medpage today. The drug’s label also includes a warning for cytokine release syndrome, an overly aggressive immune response to treatment.

To help pay, one of the companies that make the drug, Provention Bio, will offer a patient assistance program, a spokesperson told NBC News via email. Direct costs will depend on patients’ insurance coverage, according to the publication.

Currently, most people who are screened for early signs of type 1 diabetes have immediate family members who have been diagnosed, for Medscape. But 85 percent of people with type 1 diabetes don’t have a direct family member with it, according to the Schedules. So for the treatment to reach more people, screening will have to expand.

“The most important thing right now is finding the potential patients,” said Jeffrey A. Bluestone, an endocrinologist who worked on the clinical trial and was a board member of one of the drugmakers. Schedules.

First Drug to Slow Type 1 Diabetes Approved by the FDA | smart news

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