Ritlecitinib will likely benefit from its first-in-class status, rapid onset of action and expected label for both adults and adolescents, potentially providing an effective option to stimulate hair growth in a stigmatizing disease. It is currently the only JAK inhibitor being evaluated for adolescent patients who are the most likely to aggressively seek care for a disorder that profoundly affects their physical appearance.
Ritlecitinib is the first in a new class of oral, highly selective kinase inhibitors. It is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3).
• NDA accepted: U.S. FDA
• MAA accepted: EMA
• 2023: United States
• 2024: Europe
Patents estimated to expire beginning in 2039
How will ritlecitinib impact the market for alopecia areata?
This large and under-served market is expected to grow to as much as $2.5 billion by 2030 in the United States and the top five European markets (Germany, France, the U.K., Spain and Italy), largely driven by JAK inhibitors. Ritlecitinib’s broad target population and first-in-class status are expected to help it achieve a 2.0% and 1.4% share of drug-treated patients in the United States and the top five European markets, respectively, by 2030.
What gaps in treatment does ritlecitinib fill?
Alopecia areata often causes hair loss at the scalp but can also affect eyebrows, eyelashes, facial hair and other areas, leading to a potentially negative impact on patients’ daily lives and a significant emotional burden. First-line therapy for new diagnoses are topical corticosteroids, which vary in their effectiveness at hair regrowth.
What hurdles might it need to overcome to reach blockbuster status?
Given the existing concerns about safety issues associated with JAK inhibitors, adoption will likely depend on the safety data from the phase 3 ALLEGRO-LT trial. This is especially true given alopecia is primarily a cosmetic disease, for which the benefit will need to outweigh the risk. Competition from other JAK inhibitors in the market or in late-stage development could also limit uptake.
“It is important that adolescent patients are being included in pivotal trials because adolescents are often the patients most profoundly affected by alopecia areata.”
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