zevaskyn (prademagene zamikeracel) · Abeona Therapeutics Inc.

No clinical studies have been conducted to evaluate the pharmacokinetics of ZEVASKYN.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to the rates in the clinical trials of another product and may not reflect the rates observed in practice. The safety data described in this section reflects exposure of 11 patients to ZEVASKYN in the VIITAL study [see Clinical Studies ( 14 ) ] . The median number of sheets patients received was 6 (range 3-6), and the total exposure time was 6 months following ZEVASKYN application. The most common a...

The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Abeona Therapeutics Inc at 1-844-888-2236 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to the rates in the clinical trials of another product and may not r...

None. None.

Hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. ( 5.1 ) Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. ( 5.2 ) Transmission of Infectious Agents may occur because ZEVASKYN is manufactured using human- and bovine-derived reagents. ( 5.3 ) 5.1 Hypersensitivity Reactions Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN ...