Provention Bio's TZIELD (teplizumab-mzwv) Receives the US FDA's Approval of BLA for the Treatment of Stage 2 Type 1 Diabetes
- The US FDA has approved the BLA for TZIELD (anti-CD3-directed Ab) in adult and pediatric patients aged ≥8yrs. with stage 2 T1D. TZIELD inj. is provided as a sterile, preservative-free, clear & colorless solution in a 2mg/2mL (1mg/mL) single-dose vial for IV use
- Under the terms of a co-promotion agreement with Sanofi in Oct 2022, the companies collaborated to launch TZIELD in the US for the delay in the onset of clinical T1D in at-risk individuals
- The company has launched a patient support program i.e., COMPASS that provides access to patients to use TZIELD & also offers financial assistance options i.e., copay assistance for out-of-pocket costs to eligible patients
Ref: Provention Bio | Image: Provention Bio
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