---
title: Teens With Severe Alopecia Areata Now Have a Second FDA-Approved Pill
description: The FDA approved Olumiant for ages 12 and up with severe alopecia areata, the second pill for teens after Litfulo. What the trial showed and the risks.
author: Dr Marina Nani (Editor-in-Chief)
date: 2026-09-27T13:01:33.084Z
updated: 2026-09-27T13:01:33.093Z
canonical: https://richhealthmagazine.com/article/olumiant-fda-approval-teens-severe-alopecia-areata
image: https://cdn.nanimediahouse.com/pexels-doctor-discusses-with-family-during-a-medical-consultation-p-39192347.jpg
categories: Health
content_type: News
region: United States
publication: Rich Health Magazine
schema_type: Article
---

On Sept. 25, 2026, the FDA approved Olumiant (baricitinib), Eli Lilly's once-daily pill, for people 12 and older with severe alopecia areata, a chronic immune-mediated disease that causes unpredictable hair loss. Before this approval, the only pill approved for teenagers with the disease was Litfulo (ritlecitinib), which the FDA approved for patients 12 and older in June 2023.

The FDA first approved Olumiant for adults with severe alopecia areata in 2022, the first time the agency had approved a pill specifically for the disease, according to the National Alopecia Areata Foundation (NAAF). The European Commission approved it for adolescents aged 12 to under 18 in April 2026. A third pill in the same drug class, Leqselvi (deuruxolitinib), is approved only for adults 18 and older and is taken twice a day, NAAF says.

## In Lilly's Trial, 42% of Teens on the Higher Dose Had at Least 80% Scalp Coverage at 36 Weeks

The FDA based its decision on 36 weeks of results from the teenage group in BRAVE-AA-PEDS, a Phase 3 trial Lilly describes as the first and largest designed specifically for young people with severe alopecia areata. The teens, aged 12 to 17 and weighing at least 30 kilograms (about 66 pounds), had lived with the disease for an average of 6.4 years, and at least half of them had no scalp hair at all when they enrolled. Dr. Brittany Craiglow, an adjunct associate professor of dermatology at Yale School of Medicine and an author of updated BRAVE-AA-PEDS results presented in July 2026, said severe alopecia areata "that starts early in life can be more extensive and harder to treat over time."

The first group of 257 teens was split evenly among a 4 mg daily dose, a 2 mg daily dose and a placebo. After 36 weeks, 42% of teens on 4 mg and 27% on 2 mg had 80% or more of their scalp covered with hair, compared with 5% on placebo. Coverage of 90% or more was reached by 37% on 4 mg, 21% on 2 mg and 2% on placebo. Teens on 4 mg who started with substantial eyebrow and eyelash loss also had improved eyebrow and eyelash coverage, according to Lilly.

A second group of 166 teens received either 4 mg or 2 mg, with no placebo, so the researchers could collect more safety data. Lilly says the safety results in teens were consistent with those in adults with severe alopecia areata.

> "More treatment choices mean more families have the opportunity to find the option that's right for their child, together with their doctor."
> — George Gondo, Chief Mission Officer, National Alopecia Areata Foundation

## Olumiant Has a Boxed Warning and Requires Regular Blood Tests

Olumiant's US label includes a boxed warning for serious infections, death, cancer, major heart problems such as heart attack and stroke, and blood clots. The infections named include tuberculosis, shingles and others caused by bacteria, fungi or viruses, and some people have died from them. According to the label, the higher risks of death, heart problems and blood clots were seen in people 50 and older with at least one heart disease risk factor who took drugs in Olumiant's class, known as JAK inhibitors.

Under the label, a doctor should test for tuberculosis before treatment starts, order blood tests before and during treatment, and check cholesterol about 12 weeks after the first dose. People taking Olumiant should not receive live vaccines. The recommended dose is 2 mg a day, and the label allows 4 mg for patients whose response is inadequate or who have nearly complete or complete scalp hair loss.

Lilly says three of the largest pharmacy benefit managers cover Olumiant for adults with severe alopecia areata, and it offers co-pay assistance to eligible patients with commercial insurance. Coverage varies by plan, NAAF says.

## Children Under 12 Still Have No Approved Treatment

The FDA's decision covers patients 12 and older only, and Olumiant's label says it is not known whether the drug is safe and effective in children younger than 12 with severe alopecia areata. NAAF says there are [no FDA-approved treatments for alopecia areata in children under the age of 12](https://www.naaf.org/navigation-toolkit/fda-approved-jak-inhibitors/), and that dermatologists may prescribe adult-approved JAK inhibitors off-label for younger children.

BRAVE-AA-PEDS is [still recruiting patients aged 6 to 17](https://clinicaltrials.gov/study/NCT05723198), with an estimated enrollment of 595, according to its ClinicalTrials.gov listing. The listing gives March 2028 as the estimated date for completing the trial's main measurements, and some participants may stay on treatment for up to 180 weeks through a long-term extension.

## FAQ

**Q: Is alopecia areata common in teenagers?**
As many as 2% of people develop alopecia areata at some point in their lives, and nearly 40% of cases begin before age 20, according to Lilly.

**Q: What is the newest treatment for alopecia areata?**
The newest FDA-approved treatments are JAK inhibitors, pills that NAAF says target the immune pathway that is overactive in alopecia areata, blocking the immune attack on the hair follicle so the normal hair growth cycle can continue. NAAF considers JAK inhibitors the first-line treatment for severe alopecia areata, including the forms known as alopecia totalis and alopecia universalis.

**Q: What is the most common side effect of baricitinib?**
In people treated for alopecia areata, the most common side effects on Olumiant's label include upper respiratory tract infections such as colds and sinus infections, headache, acne and increased cholesterol levels. The longer list also includes urinary tract infections, tiredness, nausea, shingles and weight gain.