Saudi Gazette report
RIYADH — The Saudi Food and Drug Authority (SFDA) has approved the registration of Tzield (teplizumab) to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and above with Stage 2 type 1 diabetes (T1D).
Tzield is the first drug of its kind to be approved for this medical indication, the SFDA said in a statement. It is a monoclonal antibody that targets CD3, a cell surface antigen on T lymphocytes. By binding to these cells, the product helps to inhibit their activity or decrease their number, which aids in restoring immune balance and delaying disease progression.
The product is administered to patients with confirmed Stage 2 T1D, characterized by the presence of at least two positive pancreatic islet autoantibodies and abnormal blood glucose levels, in the absence of type 2 diabetes. It is given as a daily intravenous infusion for 14 consecutive days and is not repeated thereafter.
The SFDA approved Tzield following a comprehensive assessment of the totality of evidence, including its efficacy, safety, and quality, in line with the applicable regulatory standards. Clinical trial data demonstrated that Tzield significantly delayed the onset of stage 3 type 1 diabetes compared to placebo in high-risk individuals with positive autoantibodies who had not yet developed symptoms.
Results showed that the median time to diagnosis was extended by 24.6 months in the Tzield group compared to the placebo group. The most frequently reported adverse events in clinical studies were lymphopenia, rash, leukopenia, and headache. The drug also carries warnings and precautions related to risks of cytokine release, infections, lymphopenia, and hypersensitivity reactions.
This approval reflects the SFDA’s commitment to expanding therapeutic options, fostering an environment that encourages research and innovation, and providing patients with novel treatments that improve quality of life. It also supports the advancement of a sustainable healthcare system in line with the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.
