Sanofi/formerly Provention’s Tzield (teplizumab), a CD3 mAb, is the only FDA-approved disease-modifying therapy that delays progression of Stage 2 T1D in patients 8 years and older. However, less than half of U.S. clinicians are impressed with the drug’s ability to delay T1D onset.
NEWTON, Mass., July 11, 2023 /PRNewswire/ — Type 1 Diabetes (T1D) is a life-long autoimmune disease where the immune system destroys the insulin-producing islet cells in the pancreas until they no longer produce insulin. To date, insulin replacement therapy has been the backbone of T1D treatment but has a significant treatment burden on patients. Recently, clinical development appears to be shifting towards therapies that could delay the need for insulin and preserve beta cell function.
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The launch of Tzield is an important milestone in T1D disease management in that patients in the pre-diabetic stage now have an option to delay T1D onset by ~2 years, thereby delaying insulin use. Further, the approval has increased interest and awareness around screening patients who may be at risk for the disease.
While the approval of Tzield has created excitement amongst clinicians, the response to its efficacy and dosing is underwhelming; less than 30% of interviewed doctors reported that they found the dosing impressive, according to REACH Market Research‘s MarketVue® assessment.
Endocrinologist, U.S.: “What are the potential benefits of a drug like teplizumab in a person who has stage 2 diabetes? It is not a magical bullet, but it’s a good start.”
The current T1D pipeline consists largely of insulin-based treatments with few therapies in development to delay T1D and insulin use in recent-onset patients, including:
- Sanofi’s teplizumab label extension for patients 0-7 yrs and recent-onset T1D
- NIDDK’s anti-thymocyte globulin and granulocyte colony-stimulating factor
- Diamyd Medical AB’s Diamyd, a glutamic acid decarboxylase 65 (GAD65)-specific immunotherapy
- Dompe Farmaceutici S.p.A’s ladarixin, an anti-IL-8, CXCR1 and CXCR2 inhibitor
- Novartis’ iscalimab, an anti-CD40 mAb
Endocrinologists interviewed by REACH are eager for preventative treatments that offer a longer time to T1D progression and more convenient dosing than Tzield.
Meghana Pandit, REACH Analyst: “Tzield as a concept is viewed favorably by physicians, however, there are concerns around its dosing, and efficacy profile which is reported as marginal.”
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