Drug that delays onset of type 1 diabetes gets approval in US

130

Federal regulators have approved a new drug teplizumab that can delay the onset of type 1 diabetes by at least 2 years.
The drug, which is sold under the brand name Tzeid, is available for adults and children 8 years and older who currently have stage 2 diabetes.
The drug is administered by intravenous infusion once a day for 14 consecutive days.
Members of the diabetes community say Tzeid has the potential to be a ground-breaking treatment.
The Food and Drug Administration has approvedTrusted Source a new drug that regulators say can delay the onset of type 1 diabetes.

FDA officials said the injectable drug, teplizumab, can postpone the onset of type 1 diabetes by at least 2 years.

The drug, known by the brand name Tzield, is available for adults and children 8 years and older who currently have stage 2 type 1 diabetes.

It is administered by intravenous infusion once a day for 14 consecutive days.

It’s not recommended for people with insulin-dependent stage 3 type 1 diabetes or for people diagnosed with type 2 diabetes.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said Dr. John Sharretts, the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a statement. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

FDA officials said Tzield works by binding to certain immune cells.

“Tzield may deactivate the immune cells that attack insulin-producing cells while increasing the proportion of cells that help moderate the immune response,” the FDA officials explained.

Members of the diabetes community said the new drug could be a game changer.

“This approval is a watershed moment for the treatment and prevention of type 1 diabetes,” Dr. Mark Anderson, director of the University of California San Francisco Diabetes Center, told ABC News. “Until now, the only real therapy for patients has been a lifetime of insulin replacement. This new therapy targets and helps to halt the autoimmune process that leads to the loss of insulin.”

A long approval process for type 1 diabetes drug
In May 2021, an FDA advisory committee recommended teplizumab be approved by the full agency.

In June 2022, the FDA opted to delay approval of the drug while its manufacturer, Provention Bio, retooled the medication.

“I will say with confidence that years from now, teplizumab will widely be seen as revolutionary, and in fact for some, including myself, I have already seen it in such a light,” Dr. Mark Atkinson, American Diabetes Association Eminent Scholar for Diabetes Research and director of the University of Florida Diabetes Institute, wrote in his testimony to the FDA earlier this year.

He called teplizumab the most impactful diabetes breakthrough since home blood glucose meters replaced urine testing.

Others agreed.

“We know this can have a blockbuster effect on the pre-diagnosed,” said Frank Martin, PhD, the director of research at JDRF, a global research and advocacy organization for type 1 diabetes.

What is teplizumab?
Teplizumab is an anti-CD3 monoclonal antibody drug that binds to the surface of T-cells in the body and helps suppress the immune system.

Similar drugs are being tested for the treatment of other conditions such as Crohn’s disease and ulcerative colitis.

FDA officials reportedTrusted Source that teplizumab performed well in a recent clinical trial involving 76 people with stage 2 type 1 diabetes

After a median follow-up of 51 months, researchers reported that 45% of the 44 people who were given Tzield were later diagnosed with stage 3 type 1 diabetes. That compared with 72% of the 32 people who received a placebo.

Researchers noted that the mid-range time between administration of the drug and stage 3 diagnosis was 50 months for people who received Tzaid and 25 months for those who were given a placebo.

The most common side effects were decreased levels of certain white blood cells, rashes, and headaches.