Litfulo: animal efficacy model or human cells?

“Intravenously administered ritlecitinib at 30mg/kg prevented the onset of AA by effectively reducing AA-associated skin inflammation (e.g. supported by data from immunofluorescence and flow cytrometric analysis) and avoiding hair loss in C3H/HeJ skin grafted mice.”

“the applicant justified that exposure data of ritlecitinib after oral administration (the proposed route of administration in human) in AA mice and data on symptoms, markers of neuroinflammation and molecular data upon ritlecitinib withdrawal were not available as the study in AA mice was performed solely with the intention to demonstrate that JAK3 inhibition would improve symptoms of AA.”

“Therefore, experiments performed by the applicant in animal models of diseases for different indications are considered as supportive only. Studies and assays submitted by the applicant are acknowledged and considered acceptable to the CHMP.”