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Baldness is a sudden limitation of plaque-like hair loss, no difference in the incidence of men and women, can occur at any age, but with youth and adults more common.
the cause of baldness is unknown, but there are lymphocytes soaked around the follicles, and sometimes combined with other autoimmune diseases (such as vitiligo, ad hoc dermatitis), so it is also believed that the occurrence of spot baldness may have an autoimmune pathogenesis.
hairs in the bald areas are multi-renewable, but they can also be recurrent.
FDA has not approved any drugs to treat baldness.
FDA's decision is based primarily on the positive results of the II/III BRAVE-AA1 study.
in Phase II, 36 weeks of treatment results showed that no new serious adverse events were detected compared to placebo, and the treatment-related adverse events were mild to moderate, including upper respiratory tract infections, nanussitis, and acne.
based on the interim analysis of the brave-AA1 study phase II, the BRAVE-AA1 study Phase III and another Phase III study, codenamed BRAVE-AA2, have been initiated to assess the efficacy and safety differences between baricitinib 2mg and 4mg placebos.
baricitinib is a JAK1/2 inhibitor currently approved for the treatment of moderate to severe rheumatoid arthritis in adults.
JAK kinase is an intracellular family of non-receptor tyrosine kinase with four members, JAK-1, JAK-2, JAK-3 and TYK-2.
the signaling conduction of most cytokines in JAK kinase-mediated cells, such as interleukin (IL), interferon (IFN), etc., and different receptors activate different subtypes of JAK kinases to perform differentiated biological functions.
therefore, the potential indications of JAK inhibitors are also very diverse.
the development of baricitinib's indications also include systemic lupus erythematosus, adhesterisive dermatitis, psoriasis and so on.
Source: Lotus Mallbris, Vice President of Immune Product Development at Next Pharma Lilly, Pharmaceutical Rubik's Cube, said: "No FDA-approved drugs are currently available in patients with baldness.
baldness not only causes local hair loss in the patient's body, but also causes a huge mental burden on the patient.
Lilly expects to be able to offer the first therapeutic drug option for patients with baldness.
"