Pfizer's JAK3 Inhibitor Ritlecitinib Receives FDA Approval for Alopecia Areata with 80% Hair Regrowth Demonstrated

On June 23, Pfizer announced that the FDA had approved its JAK3 inhibitor Ritlecitinib (Ritlecitinib Capsules) for marketing, used to treat alopecia areata in adolescents aged 12 years and above and adults.

Ritlecitinib is a once-daily oral specific JAK3/TEC inhibitor. It has high selectivity for tyrosine kinase members of the TEC kinase family expressed in hepatocellular carcinoma (TEC) and Janus kinase 3 (JAK3). It can block signaling molecules and immune cell activity that lead to alopecia areata, thereby inhibiting the immune system from attacking hair follicle cells to achieve the purpose of treating alopecia areata. Compared with first-generation pan-JAK inhibitors, Ritlecitinib has more advantages in reducing toxicity.

The approval for marketing this time is based on the randomized, double-blind, placebo-controlled Phase IIb/III ALLEGRO study. This study aims to evaluate the efficacy and safety of Ritlecitinib in treating patients aged 12 years and above with alopecia areata (n=718). Enrolled patients had at least 50% hair loss due to alopecia areata, including those with total scalp hair loss (alopecia totalis) and total body hair loss (alopecia universalis), and had experienced episodes of alopecia areata lasting from 6 months to 10 years. Patients were randomly assigned to receive either Ritlecitinib 30mg or 50mg once daily (with or without an initial treatment of Ritlecitinib 200mg once daily for one month), Ritlecitinib 10mg, or a placebo.

The primary endpoint was the proportion of patients with absolute SALT score ≤20 at week 24 who achieved scalp hair regrowth after receiving Ritlecitinib treatment. SALT is a tool used to measure the amount of scalp hair loss, with higher scores indicating more severe hair loss. The results showed that after 24 weeks of daily treatment with 30mg or 50mg Ritlecitinib, the proportion of patients achieving ≥80% scalp hair coverage was significantly higher than in the placebo group, meeting the primary efficacy endpoint.

Moreover, Ritlecitinib demonstrated good tolerability and safety in both adult and adolescent patients. The most common adverse events were headache, nasopharyngitis, and upper respiratory tract infections.

Another ongoing open-label, long-term Phase III ALLEGRO-LT study aims to evaluate the safety and efficacy of ritlecitinib in adult patients with alopecia areata who have a hair loss rate of 25% or more and in adolescent patients aged 12 years or older with alopecia areata who have a hair loss rate of 50% or more.

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 cause 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.

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