Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, has announced that the United States Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for Tzield (teplizumab-mzwv), an anti-CD3-directed antibody, for intravenous use, as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D.

• TZIELD injection is supplied as a sterile, preservative-free, clear, and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. TZIELD should be administered by intravenous infusion (over a minimum of 30 minutes) once daily for 14 days.
• TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections.
• The most common adverse reactions (>10%) that occurred during treatment and through 28 days after the last study drug administration from the TN-10 study were lymphopenia), rash, leukopenia and headache.
• Read more… https://www.drugs.com/history/tzield.html