Litfulo FDA Approval History
Last updated by Judith Stewart, BPharm on June 27, 2023.
FDA Approved: Yes (First approved June 23, 2023)
Brand name: Litfulo
Generic name: ritlecitinib
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Alopecia
Litfulo (ritlecitinib) is a covalent kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
- Alopecia areata is an autoimmune disease caused by an immune system attack on the hair follicles, which causes the hair to fall out. It is characterized by patchy hair loss, almost always involving the scalp.
- Litfulo contains ritlecitinib which is a covalent kinase inhibitor with high selectivity for Janus kinase 3 (JAK3). Litfulo is thought to work by blocking the signaling of cytokines and cytolytic activity of T cells, which is implicated in the pathogenesis of alopecia areata.
- Litfulo capsules are administered orally once daily.
- The Litfulo product label carries a Boxed Warning for the increased risk of serious infections, higher rate of all-cause mortality, malignancies, higher rate of major cardiovascular events (MACE), and thrombosis.
- Warnings and precautions associated with Litfulo include hypersensitivity reactions and laboratory abnormalities.
- Common adverse reactions include headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, increased blood creatine phosphokinase, herpes zoster, decreased red blood cell count, and stomatitis.
Development timeline for Litfulo
Further information
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