Eli Lilly’s Olumiant (baricitinib) has received FDA approval as a once-daily pill to treat paediatric patients 12 years of age and older with severe hair loss (alopecia areata) (AA). The approval builds on Olumiant’s established use in adults with moderately to severely active rheumatoid arthritis and severe alopecia areata (AA).

AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives, and nearly 40% of cases occur before the age of 20. Early-onset AA can be more severe and lead to extensive hair loss.

The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of BRAVE-AA-PEDS, the first and largest phase 3 study specifically designed to evaluate paediatric patients with severe AA. At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years.

At Week 36, treatment with once-daily Olumiant delivered:

- 80% or more scalp hair coverage, as measured by a SALT score ≤20, in 42% of patients treated with Olumiant 4mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo.

- 90% or more scalp hair coverage, as measured by a SALT score ≤10, in 37% of patients treated with Olumiant 4mg and 21% treated with Olumiant 2mg, compared with 2% receiving placebo.

- Improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4mg.

The overall safety profile observed in paediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA. The FDA-approved labelling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.

In 2022, the FDA approved Olumiant for adult patients with severe AA, making it the first systemic treatment approved in the US for this condition. In April 2026, the European Commission also approved Olumiant for the treatment of adolescents (ages 12 to under 18) with severe AA.

MSD, known as Merck in the US and Canada, has announced the first presentation of results from MK-7240-012, a phase 2b multicentre, randomised, double-blind, placebo-controlled trial evaluating tulisokibart, an investigational humanised monoclonal antibody targeting tumour necrosis factor-like cytokine 1A (TL1A), in patients with moderate-to-severe hidradenitis suppurativa (HS).

The results mark the first positive phase 2 data for an anti-TL1A monoclonal antibody in dermatology, with the data presented in a Late-Breaking News session at the European Academy of Dermatology and Venereology (EADV) 2026 Congress.

The study met its primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16 for patients treated with both high-dose and medium-dose tulisokibart regimens, demonstrating superiority over placebo. Specifically, 72% of patients in the high-dose group and 64% in the medium-dose group achieved HiSCR50, representing a 37% and 29% improvement over the placebo group, respectively. In an exploratory analysis, the low-dose group achieved a 52% response rate, a 17% improvement over placebo. There was comparable safety between tulisokibart and placebo groups in this trial.