Ritlecitinib filed in Japan for alopecia areata treatment .- Pfizer
Pfizer has filed a new drug application in Japan to market the oral JAK3/TEC kinase inhibitor ritlecitinib for the treatment of alopecia areata.
The application was made based on data collected from multiple clinical trials including a global PII/III study, dubbed ALLEGRO-IIb/III, as well as a PIII clinical study, ALLEGRO-LT, the drug maker said. In the ALLEGRO-IIb/III trial, the drug was investigated in a total of 718 alopecia areata patients 12 years of age and older, with at least 50% scalp hair loss due to the disease, including alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).
Ritlecitinib 50 mg and 30 mg achieved the primary efficacy endpoint of the study, which was the proportion of patients with less than or equal to 20% scalp hair loss after 24 weeks of treatment versus placebo.
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