(RxWiki News) The US Food and Drug Administration (FDA) has given the green light to a first-in-class diabetes injection.
This new approval is found under the name Tzield (teplizumab-mzwv). It's an injection given once daily for 14 consecutive days.
The FDA approved it to delay the onset of stage 3 type 1 diabetes in both adults and children 8 years and older.
"Today’s 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 FDA's Division of Diabetes, Lipid Disorders, and Obesity, in a press release. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease."
Type 1 diabetes happens when the immune system destroys the cells that make insulin. As a result, those with type 1 diabetes can’t make enough insulin on their own and, therefore, need insulin shots or an insulin pump to survive.
Type 1 diabetes is usually diagnosed in children and young adults.
According to the Centers for Disease Control and Prevention (CDC), around 1.45 million Americans are living with type 1 diabetes. And the number of new cases of type 1 diabetes in the US is estimated at 64,000 each year.
By the year 2040, 2.1 million people in the US are expected to have type 1 diabetes.
This newly improved injection works to delay progression to stage 3 type 1 diabetes by binding to certain immune system cells. Once bound, this medication is thought to stop the cells from attacking insulin-producing cells.
A randomized clinical trial tested the safety and effectiveness of Tzield. Those who got the injection saw a longer time to onset of stage 3 type 1 diabetes.
Common side effects included changes in certain white blood cells, rash and headache.
There are some possible serious side effects, which include the following:
- Cytokine Release Syndrome (CRS). Symptoms include fever, feeling tired, muscle and joint pain, nausea and headache. These symptoms usually start during the first five days of treatment.
- Serious infections
- Decreased levels of lymphocytes (a type of white blood cell). Your healthcare provider will run blood tests (to check your liver and your complete blood counts) before you start treatment, as well as during treatment.
If you have recently received or are scheduled to receive a vaccine, tell your healthcare provider. This medication may affect how well a vaccine works.
The FDA granted this approval to Provention Bio.