FDA OKs First Systemic Treatment for Alopecia
The FDA has just approved baricitinib oral tablets as the first systemic treatment for adult patients with severe alopecia areata. In patients with the autoimmune disorder, the body attacks its own hair follicles and hair falls out, often in clumps. In February, the FDA granted priority review for baricitinib in adults with severe AA. Baricitinib is a JAK inhibitor, which blocks the activity of one or more enzymes, interfering with the pathway that leads to inflammation. The FDA reports the most common side effects include upper respiratory tract infections, headache, acne, hyperlipidemia, increase of creatinine phosphokinase, urinary tract infection, elevated liver enzymes, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, Candida infections, anemia, neutropenia, abdominal pain, herpes zoster (shingles), and weight gain. The labeling for baricitinib includes a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
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