Lilly and Incyte Announce FDA Breakthrough Therapy Designation for Baricitinib in Alopecia Areata

On March 16, Eli Lilly and Incyte announced that the FDA granted “Breakthrough Therapy” designation to baricitinib for the treatment of alopecia areata.

Alopecia areata is a sudden-onset, localized patchy hair loss. There is no difference in incidence between males and females, and it can occur at any age, although it is more common in young adults. The etiology of alopecia areata remains unclear; however, lymphocytic infiltration around hair follicles and its occasional association with other autoimmune diseases (such as vitiligo and atopic dermatitis) suggest that an autoimmune mechanism may be involved in its pathogenesis. Hair in the affected areas often regrows, but recurrent episodes are possible. No drugs have been approved by the FDA for the treatment of alopecia areata.

The FDA’s decision was primarily based on the positive results from the Phase II/III BRAVE-AA1 study. During the Phase II stage, 36-week treatment results showed that baricitinib did not reveal any new serious adverse events compared to placebo. Treatment-related adverse events were all mild to moderate in severity, mainly including upper respiratory tract infections, nasopharyngitis, and acne.

Based on the interim analysis results from the Phase II stage of the BRAVE-AA1 study, the Phase III stage of the BRAVE-AA1 study and another Phase III study coded as BRAVE-AA2 have been initiated, primarily to evaluate the efficacy and safety differences between baricitinib 2 mg and 4 mg compared with placebo.

Baricitinib is a JAK1/2 inhibitor currently approved for the treatment of moderate-to-severe rheumatoid arthritis in adults. Janus kinases (JAKs) constitute a family of intracellular non-receptor tyrosine kinases, comprising four members: JAK1, JAK2, JAK3, and TYK2. JAK kinases mediate the intracellular signaling of most cytokines, such as interleukins (ILs) and interferons (IFNs). Different receptors can activate distinct JAK isoforms, thereby eliciting diverse biological functions. Consequently, JAK inhibitors have a wide range of potential indications. The indications under development for baricitinib also include systemic lupus erythematosus, atopic dermatitis, and psoriasis.

Source: PharmaCube NextPharma

Lotus Mallbris, Vice President of Immunology Product Development at Eli Lilly, stated, “There are currently no FDA-approved therapies available for patients with alopecia areata. Alopecia areata not only causes localized hair loss but also imposes a significant psychological burden on patients. Eli Lilly aims to provide the first therapeutic option for patients with this condition.”