The first ever drug to prevent and delay the onset of type 1 diabetes (T1D) in patients at a higher risk of developing it in the short term—a new injectable medication with an unusual name, Teplizumab—is about to be approved and made available on the U.S. market.
On May 27, 2021, the U.S. Food and Drug Administration (FDA) recommended that Teplizumab be approved.
What is Teplizumab?
This medication helps to suppress the immune response by inhibiting the action of T lymphocytes, which play an important part in immunity. T1D is the result of an immune response—where the immune system destroys the pancreas’s insulin-producing beta cells—and this medication could impede this process.
Other medications with similar modes of action are currently being tested for treating other conditions such as Crohn’s disease and ulcerative colitis.
The Teplizumab treatment will consist in injections given in an outpatient clinic over a two-week period. There are very few adverse side effects, except for a potential minor rash.
A breakthrough for people at a higher risk of developing T1D
A clinical study published in 2019 found that a 14-day Teplizumab treatment in people who are at a higher risk of developing T1D successfully delayed the onset of type 1 diabetes for two years on average.
People are considered at a higher risk when their blood sugar levels are unusually high following the glucose tolerance test, when their blood contains at least two T1D-related antibodies and when they have not yet received a T1D diagnosis. It is important to note that in Quebec, only one antibody can be measured out; and it is not yet established whether it should be done in the absence of symptoms in people who are at risk, for instance a child of someone with T1D.
Teplizumab could have the following benefits for people who are at risk:
- Pushing back the need for insulin
- Delaying the onset of T1D-related complications
- Giving patients and their families more time to cope with an eventual diagnosis
A second dose could potentially be offered later on to further delay the onset of T1D, and the medication could even be given to newly diagnosed T1D patients to help with blood sugar management.
Detecting T1D and stopping it in its tracks
The need for medications that can delay, stop or revert the progression of T1D is ever-growing.
In December 2020, JDRF launched the T1Detect Initiative in the U.S., pushing for the screening of autoantibodies that are considered the greatest indicators of T1D progression. This screening could be done, for instance, in siblings of people with T1D.
People with a high rate of several autoantibodies are at a higher risk of developing T1D and should Teplizumab get approved, they could benefit from its action before diagnosis.
The FDA is set to vote on the authorization on July 2, 2021.
Some experts think that more studies are needed before the drug gets approved. Even if the medication doesn’t get approved this year, we are certainly getting closer to the day when it is available as a treatment.
Teplizumab would be the first drug to get approved in the U.S.—and eventually, in Canada—with the ability to delay the onset of T1D. Understandably, this is creating a lot of excitement.
Another potential way to prevent T1D: a vaccine with the ability to stop the autoimmune response. But we are not expecting this kind of therapy to be available anytime soon.
- Herold KC, Bundy BN, Long SA, and al. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. The New England Journal of Medicine. 2019 Aug;381(7):603-613.
- FDA Advisory Committee Recommends that Teplizumab Receives Approval, 14 juin 2021, https://www.jdrf.org/blog/2021/05/27/fda-advisory-committee-recommends-teplizumab-receives-approval/
- Teplizumab : ce nouveau médicament passionnant pour prévenir le diabète de type 1, 14 juin 2021, https://infosante24.com/teplizumab-ce-nouveau-medicament-passionnant-pour-prevenir-le-diabete-de-type-1/