FDA Approves AVITA Medical Vitiligo Trial With Fewer Participants

The FDA has approved AVITA Medical Inc's RCEL request to amend its pivotal trial evaluating RECELL System for the repigmentation of stable vitiligo lesions to a streamlined single-arm trial design.
The Company will pursue a single cell suspension formulation (1:20 expansion ratio) against the three cell suspensions in the initial trial design.
The new single-arm design will evaluate 23 subjects at 15 clinical sites versus a previously approved 3-arm study of 84 subjects.
The primary effectiveness evaluation is based on comparing the incidence of successful repigmentation with RECELL versus that of a standard of care control.
Long-term durability data (assessing sustained repigmentation over 52 weeks) will be collected.
As with the previous design, an interim analysis will be conducted on 24-week data for approximately half of the subjects to evaluate the sufficiency of the sample size, with a possible increase to sample size as needed (up to 46 subjects).
Vitiligo is a disease resulting in loss of color or pigmentation in patches of skin.
Price Action: RCEL shares are down 0.72% at $17.26 during the market session on the last check Monday.
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