On May 5, 2025, Sanofi announced Health Canada approval of Tzield, the first disease-modifying therapy for type 1 diabetes (T1D). This is a huge win for the T1D community in that it is the first medicine to be approved in Canada that addresses the autoimmunity behind T1D – not just the symptoms that is causes.
Jessica Diniz, President and CEO of Breakthrough T1DTM Canada, celebrated the decision:
“The approval of the first disease-modifying therapy for type 1 diabetes in Canada is a milestone for our community, after supporting research on this challenge for many years. Delaying the need for insulin therapy will significantly benefit those with early-stage type 1 diabetes, their families, and the healthcare system. It will provide much-needed time to prepare for and understand disease management and reduce fears of complications.”
What we know:
- TZIELD (Teplizumab) is indicated to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes.
- Tzield has been shown to delay the onset of a clinical T1D diagnosis by a median of 2 years. Clinical diagnosis (stage 3) is defined by the onset of symptoms requiring insulin therapy.
- Tzield administration requires a 14-day infusion protocol which requires some or all treatment days to occur in an infusion clinic.
- Screening tests to identify individuals in stage 2 (early-stage T1D) are currently only available in Canada for relatives of family members living with T1D via TrialNet. Breakthrough T1D is funding research to support introduction of universal screening for T1D in many countries around the world, and in Canada this effort is being driven by CanScreen T1D.
What’s next:
Access to and coverage for Tzield will be subject to several next steps:
Recommendations for reimbursement by provincial public health plans will be made later in 2025 by Canada’s Drug Agency (CDA) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS). Breakthrough T1D led the patient advocacy group submissions to advocate for the coverage of this drug and will continue to advocate for access and coverage to Tzield on behalf of the T1D community.
Ongoing Tzield clinical trials
Tzield is only currently indicated for individuals aged 8 years and older in stage 2 T1D. However, it may also provide benefit for other groups. Clinical trials are ongoing to test the drug in children aged 0-8 years in stage 2 T1D (PETITE-T1D trial).
In addition, a recent study showed that the drug preserved beta cell function in children and teens when given within 6 weeks of a T1D diagnosis (PROTECT trial).
Breakthrough T1D will continue to monitor these trials and will update when results are available.
Our role in this historic approval
The approval of Tzield would simply not have been possible without decades of Breakthrough T1D-funded work, from funding discovery research to clinical development to work with regulators. Breakthrough T1D had a hand in funding the development of Tzield from the very beginning:
- Breakthrough T1D (then known as JDRF) gave a Career Development Award to Kevan Herold, M.D., who had just started his faculty-level career at The University of Chicago, in 1988-1990. He showed, in an early study, that he could prevent autoimmune diabetes with an anti-CD3 antibody (which laterbecame a humanized version, Tzield). He has gone on to receive more than 15 grants from Breakthrough T1D and was the lead on the clinical trial that demonstrated that Tzield could delay the onset of T1D in people almost certain to develop the disease. This was the first ever study in humans to show a delay in the onset of T1D.
- Breakthrough T1D (then known as JDRF) funded clinical trials in recent-onset disease, which were published in 2002, 2005, and 2013, and a phase III trial run by MacroGenics (it was called MGA031 at the time). MacroGenics received a Breakthrough T1D Industry Discovery and Development Program grant from 2006-2011.
- From 2010-2018, TrialNet ran the multi-national clinical trial of Tzield in at-risk individuals, led by Dr. Herold. The trial included several participants from Canada.
- In 2017, The T1D Fund (Breakthrough T1D’s venture philanthropy fund) made a strategic investment in Provention Bio, which brought the company into T1D for the first time. In 2018, Provention Bio acquired the rights to teplizumab from MacroGenics.
- In 2022, Tzield was granted FDA approval in the USA for use in individuals aged 18-35 years of age with stage 2 type 1 diabetes.
- In 2023, Sanofi acquired ProventionBio.
The success of Tzield—the first disease-modifying drug to be approved for T1D—is something that the T1D community, Breakthrough T1D, and other like-minded nonprofits, companies, stakeholders, and regulators should be gratified and proud of—but our work to find cures continues full steam ahead.
We have multiple cures therapies in the pipeline today whose path to market became a little clearer with this approval. We are moving ever closer to a world without this disease, and Tzield receiving approval is one important step along the way.
