LITFULO ritlecitinib

Drug Class

JAK3/TEC family kinase inhibitor

Mechanism

Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinases, blocking common gamma-chain cytokine signaling.

Approved Indication

Treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

What This Means For Patients

Litfulo (ritlecitinib) is a targeted kinase inhibitor indicated for adults and adolescents aged 12 and older with severe alopecia areata (autoimmune hair loss). It works by blocking signaling pathways that trigger the immune attack on hair follicles. It is approved in mainland China and also accessible in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2023) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• ALLEGRO — King et al., Lancet 2023 (NCT03732807) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215830s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo
• https://doi.org/10.1016/S0140-6736(23)00222-2