Pfizer's JAK3 Inhibitor Ritlecitinib Capsules Approved in China for Alopecia Areata with Up to 80% Hair Regrowth

On October 19, the official website of the National Medical Products Administration (NMPA) showed that Pfizer's JAK3 inhibitor Ritlecitinib Capsules (Ritlecitinib, trade name: Leukonuo) has been approved for marketing in China. It is indicated for patients with alopecia areata aged 12 years and above who are suitable for systemic treatment, including those with totalis and universalis alopecia. The indication for Ritlecitinib was granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE).

Alopecia Areata: An Autoimmune Disease Characterized by Patchy Hair LossAlopecia areata is an autoimmune disease characterized by patchy hair loss. This type of hair loss typically occurs on the scalp but can also affect eyebrows, eyelashes, facial hair, and other parts of the body. The symptoms in patients with alopecia areata are caused by immune cells attacking healthy hair follicles, leading to hair shedding. The average age of onset for alopecia areata is between 25 and 35 years, but it can also affect the elderly, children, and adolescents, with no significant gender differences. Alopecia areata severely impacts the health and quality of life of patients and may lead to serious psychological disorders, including depression and anxiety. Approximately 6.8 million people in the United States and around 147 million people worldwide are affected by alopecia areata.

Ritlecitinib Tosylate is a kinase inhibitor that irreversibly inhibits JAK3 and the tyrosine kinase family. Laboratory studies have shown that ritlecitinib can block signaling molecules and immune cell activity, which are considered to be the causes of alopecia areata. Compared with first-generation pan-JAK inhibitors, ritlecitinib has an advantage in reducing toxicity. On June 23, 2023, ritlecitinib was approved by the FDA for the treatment of alopecia areata in adolescents aged 12 years and older and adults.

A global, multicenter, randomized, double-blind, placebo-controlled pivotal Phase IIb/III ALLEGRO study evaluated the efficacy and safety of ritlecitinib in treating patients aged 12 years and older with alopecia areata (n=718, including 81 patients enrolled in China). In this study, enrolled patients had at least 50% hair loss due to alopecia areata, including those with alopecia totalis (complete loss of hair) and alopecia universalis (complete loss of all body hair), with the duration of alopecia episodes lasting from 6 months to 10 years. Patients were randomly assigned to receive once-daily ritlecitinib 30mg or 50mg (with or without an initial 1-month treatment: once-daily ritlecitinib 200mg), ritlecitinib 10mg, or placebo.

The primary endpoint was the proportion of patients with absolute SALT scores ≤20 at week 24 who responded to ritlecitinib treatment with scalp hair regrowth. SALT is a tool for measuring the amount of scalp hair loss, with higher scores indicating more severe hair loss. The results showed that the proportion of patients achieving ≥80% scalp hair coverage at week 24 was significantly higher in the groups receiving 30mg or 50mg of ritlecitinib daily (with or without an initial 4-week treatment) compared to the placebo group.

Overall safety data indicate that ritlecitinib was well-tolerated in both adult and adolescent patients. The most common adverse events were headache, nasopharyngitis, and upper respiratory tract infections.

In addition, an open-label Phase III ALLEGRO-LT study is ongoing to evaluate the safety and efficacy of ritlecitinib in adult patients with alopecia areata who have 25% or more hair loss and in adolescent patients aged 12 years or older with alopecia areata who have 50% or more hair loss.

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