Is Ritlecitinib on the market?

The European Medicines Agency(EMA) has accepted the Marketing Authorization Application (MAA) of Ritlecitinib, which has been approved for marketing by the US Food and Drug Administration (FDA) in June 2023. Alopecia areata, which affects nearly 7 million people and approximately 147 million people worldwide, can affect people of any age, gender, race or ethnicity, and can cause considerable burdens other than hair loss. Nearly 20% of people with alopecia areata are diagnosed before the age of 18.

Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body. It has an underlying immune-inflammatory pathogenesis and occurs when the immune system attacks the body's hair follicles, causing hair loss. This type of hair loss usually occurs on the scalp, but can also affect eyebrows, eyelashes, facial hair and other parts of the body. Alopecia totalis (hair loss all over the scalp) and alopecia universalis (hair loss all over the body) are types of alopecia areata. The FDA approval was based on clinical trial results for alopecia areata.

The ALLEGRO Phase 2b/3 trial enrolled 718 patients with 50% or more scalp hair loss and evaluated the efficacy and safety of rituxitinib at 118 sites in 18 countries, as measured by the Severity of Hair Loss Tool (SALT). In this pivotal study, 23% of patients treated with rifalol 50 mg achieved scalp hair coverage (salt ≤ 20) of 80% or greater after 6 months compared with 1.6% in the placebo group. Since ritexitinib is a new drug for the treatment of alopecia areata, it has not yet been marketed in China and has not been included in medical insurance. Its price has not yet been learned. For specific prices and drug details, you can consult a medical consultant.