The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D).
It is approved for intravenous use to delay the onset of stage 3 T1D in adult and paediatric patients aged eight years and older with stage 2 T1D.
“It cannot be emphasised enough how precious a delay in the onset of Stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications and risks associated with stage 3 disease” noted Ashleigh Palmer, Co-Founder and CEO of Provention Bio.
Dr Eleanor Ramos, Chief Medical Officer at Provention Bio, added: “As described in the approved label, TZIELD binds to CD3 (a cell surface antigen present on T lymphocytes) and its mechanism is believed to involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. TZIELD leads to an increase in the proportion of regulatory T cells and exhausted CD8+ T cells in peripheral blood.”
In October 2022 the company announced a co-promotion agreement for the US launch of TZIELD for delay in onset of clinical T1D in at-risk individuals with Sanofi.
Olivier Bogillot, Head of US General Medicines, Sanofi, stated: “This approval is a profound and long-awaited victory for the diabetes community. We applaud Provention Bio for its unwavering determination to bring the first ever disease-modifying therapy for T1D to patients.”
Provention Bio has launched COMPASS, a patient support program to answer questions and help navigate coverage, reimbursement and access for patients that are prescribed TZIELD. The company also offers financial assistance options to eligible patients for out-of-pocket costs.