A shot in the dark: Safety, efficacy, research lacking for pediatric medications
Pediatric dermatologist Elaine Siegfried, M.D., says that, about 80 percent of the time, she has to treat patients with drugs that have no FDA-approved indication or have never been formally studied in children.
The FDA approval, based on 36-week data from the phase 3 BRAVE-AA-PEDS trial, extends baricitinib access to patients as young as 12 years old with severe alopecia areata.