Hair loss is a thorny problem that generally puzzles middle-aged people, especially middle-aged men, and the resulting hair transplant and wig industry is booming. According to the data released by the National Health Commission, more than 250million people in China suffer from hair loss. On average, one in every six people has hair loss. Moreover, the proportion of hair loss among the "post-90s" is as high as 84%, 20 years earlier than that of the previous generation, and the trend of low age is obvious.
Hair loss mainly includes androgenic alopecia (AGA) and alopecia areata (AA). Among them, androgenic alopecia (AGA) is a genetically predetermined disease due to excessive response to androgens, which is characterized by the gradual loss of terminal hair on the scalp after puberty, accounting for about 90% of the total hair loss. Currently, the drugs approved to treat AGA alopecia are limited, only minoxidil and finasteride.
Alopecia areata (AA) is an autoimmune disease that can cause plaque like hair loss on the scalp, face and sometimes other parts of the body. Alopecia areata often occurs for the first time in childhood, and the first incidence varies from patient to patient. Alopecia areata may occur in all ages, sexes and races. Epidemiological studies show that the prevalence of AA in China is 0.27%, and foreign studies show that the lifetime prevalence of AA is about 2%.
Baricitinib is a JAK inhibitor administered orally once a day. It has been approved in more than 70 countries and regions around the world to treat adult patients with moderate to severe active rheumatoid arthritis (RA). The approved indications in China are applicable to adult patients with moderate to severe active rheumatoid arthritis who have poor efficacy or intolerance to one or more anti rheumatic drugs (DMARD). Barretinib can be used in combination with methotrexate or other abiotic anti rheumatic drugs to improve the condition.
In december2009, Lilly pharmaceutical and Incyte announced the global exclusive patent and cooperation agreement for the R & D, commercialization and related follow-up compounds of barretinib against inflammatory diseases and autoimmune diseases.
Pharnexcloud.com com； Global performance of this product in recent years
In October, 2021, Lilly and Incyte disclosed the results of two phase III clinical trials brave-aa1 and brave-aa2 conducted on 1200 patients with severe alopecia areata, which is the largest phase III clinical research project that has completed the primary endpoint. Severe alopecia areata was defined as alopecia areata with a severe alopecia severity tool (salt) score ≥ 50 (scalp alopecia area ≥ 50%). The primary end point was the proportion of patients with salt ≤ 20 (i.e. 80% or more scalp hair coverage) at week 36. In both studies, approximately one third of patients treated with 4 mg of baretinib achieved scalp hair coverage of more than 80% (brave-aa1=35.2%, brave-aa2=32.5%), compared with 5.3% (brave-aa1) and 2.6% (brave-aa2), respectively, in the placebo group.
Compared with patients taking placebo, one third of patients achieved complete regeneration or regeneration of eyebrows and eyelashes after 36 weeks of treatment with 4mg barretinib, and these patients had significant gaps or no significant eyebrows or eyelashes at baseline. (brave-aa1:4mg dose: eyebrow =31.4% [n=59]; eyelash =33.5% [n=56]; placebo: eyebrow =3.2% [n=4]; eyelash =3.1% [n=3]; brave-aa2:4mg dose: eyebrow =34.8% [n=56]; eyelash =34.3% [n=48]; placebo: eyebrow =4.5% [n=5]; eyelash =5.6% [n=5]; P ≤ 0.001 for all comparisons with placebo). Eyebrow and eyelash hair loss is the result of using clinician reported (clinro) measure for eyebrown hair loss ™ And clinro measure for eye lash hair loss, a new clinically proven tool developed by Lilly ™ For evaluation.
At the same time, the brave-aa phase III clinical project also evaluated the efficacy of Elomin ® No new safety signals were observed. Few patients in the study stopped treatment due to adverse events (2.6% or less in both studies), and the severity of adverse events in most treatments was mild or moderate.
On June 13, 2022, FDA announced that it approved baricitinib to be listed for the treatment of adult patients with severe alopecia areata, which is the first systematic therapy approved by FDA for the treatment of alopecia areata. In addition, the European Union is about to be approved: the human Medicinal Products Committee of the European drug administration supports its approval of barretinib for the treatment of adult patients with severe alopecia areata. Japanese regulators are reviewing new drug marketing applications.
