Pfizer Korea said Wednesday that its oral JAK inhibitor Litfulo Capsule 50 mg (ritlecitinib tosylate) has won approval from the Ministry of Food and Drug Safety (MFDS) for treating people with severe alopecia areata (AA).
Litfulo Capsule 50 mg is a once-daily oral Janus kinase (JAK) inhibitor approved for treating severe alopecia areata in adults and adolescents 12 years and older. It is the first and only (as of September) alopecia areata treatment approved for adolescents in Korea.
Alopecia areata is characterized by an autoimmune attack on hair follicles and is an age- and gender-independent condition.
It affects about 146 million people worldwide (as of 2018 reporting), and the number of patients in Korea reached 178,009 in 2023, up 15.3 percent from 154,380 in 2013. In the past, corticosteroids have been the mainstay of alopecia areata treatment. However, small-molecule JAK inhibitors have emerged, gradually expanding treatment options for the disease.
Litfulo’s approval is based on the results of the ALLEGRO study, conducted from December 2018 to June 2021 at 118 institutions in 18 countries and involved 718 patients with greater than 50 percent scalp hair loss.
The results showed that a statistically significantly higher proportion of patients in the Litfulo treatment arm had 80 percent or more of their scalp covered by hair (Severity of Alopecia Tool, SALT≤20) compared to placebo (23 percent in the Litfulo arm vs. 1.6 percent in the placebo group). The incidence of adverse events was similar in the Litfulo and placebo groups. There were no deaths.
“With the approval of Litfulo Capsule 50 mg in Korea, we are pleased to provide a new treatment option for patients with severe alopecia areata in adolescents, for whom there were no treatment options previously available,” said Lee Ji-eun, executive vice president and head of rare disease business division at Pfizer Korea. “We will continue to do our best to contribute to improving the treatment environment for skin immunity patients in Korea.”
Litfulo Capsule 50 mg also obtained the nod from the U.S. Food and Drug Administration (FDA) in June last year for treating severe alopecia areata in adults and adolescents 12 and older. It was the first and only FDA-approved (as of June 2023) treatment for severe alopecia areata in adolescents 12 years and older, providing a new treatment option for younger patients suffering from hair loss.