FDA approvals landed in three distinct corners of the pharmaceutical industry this week, delivering new treatment options for adolescents facing severe hair loss, adults managing Parkinson's disease, and patients living with a rare, progressive bone disorder.

Eli Lilly wins FDA approval for Olumiant

Eli Lilly and Company announced FDA has approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata. The approval expands Olumiant's U.S. label, building on its established use in adults with moderately to severely active rheumatoid arthritis and severe alopecia areata.¹

Alopecia areata is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop the condition at some point in their lives, and nearly 40% of cases occur before age 20, with early-onset disease often more severe and prone to extensive hair loss.¹

The 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 III study specifically designed to evaluate pediatric patients with severe alopecia areata.¹At baseline, the median Severity of Alopecia Tool score was 100, indicating complete scalp hair loss, and patients had been living with the disease for a mean of 6.4 years. At Week 36, 80% or more scalp hair coverage was achieved by 42% of patients on Olumiant 4 mg and 27% on Olumiant 2 mg, compared with 5% on placebo, while 90% or more coverage was reached by 37% and 21% of patients, respectively, versus 2% on placebo.¹

"Today's approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date," said Adrienne Brown, executive vice president and president of Lilly Immunology. "The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life."

AbbVie earns FDA approval for Juvmo

FDA approved Juvmo (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for the treatment of adults with Parkinson's disease.

For people living with Parkinson's disease, maintaining consistent control of motor symptoms grows more difficult as the disease progresses. Oral levodopa remains the foundation of treatment, but many patients require higher and more frequent doses over time, adjustments that can contribute to complications such as dyskinesia; about 70% of patients have their oral levodopa dose increased within the first year of therapy.² Existing dopamine agonists primarily target D2/D3 receptors and can carry tolerability concerns, while Juvmo selectively targets D1/D5 receptors instead.²

The approval was supported by Phase III data from the Tempo clinical trial program, which evaluated Juvmo in early Parkinson's patients not taking oral levodopa (Tempo-1 and Tempo-2) and as an add-on therapy for patients experiencing motor fluctuations (Tempo-3).² In Tempo-1 at week 26, Juvmo significantly improved activities-of-daily-living scores versus placebo (placebo: +0.9; 5 mg: -1.6; 15 mg: -1.7; p<0.0001 for each dose), a 22-23% improvement from baseline compared with 12% worsening on placebo, and also significantly improved combined activities-of-daily-living and motor scores.²

Juvmo showed similar significant improvements versus placebo in Tempo-2 at week 26. In Tempo-3, Juvmo plus oral levodopa significantly increased daily "on" time without troublesome dyskinesia versus placebo plus oral levodopa (1.7 hours versus 0.6 hours, p<0.0001) and reduced "off" time by 1.9 hours compared with 0.9 hours for placebo. Efficacy was sustained out to 85 weeks in the open-label extension, during which 93% of patients on Juvmo plus levodopa did not increase their levodopa dose, and 94% of patients on Juvmo alone did not initiate levodopa. Most treatment-emergent adverse events were non-serious and mild to moderate, most commonly nausea, headache, dizziness and fatigue.

"The approval of Juvmo marks the first dopaminergic breakthrough for Parkinson's disease in decades," said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer at AbbVie. "Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."

Mirum and Incyte gain FDA approval for Atebrioz

FDA approved Atebrioz (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva, a rare disease known as FOP.³

Atebrioz was developed by Incyte and licensed to Mirum for worldwide development and commercialization, and is expected to be commercially available in the U.S. in October, with eligible patients paying as little as $0 per month through Mirum's patient support program.³

Atebrioz is a once-daily oral ALK2 inhibitor designed to target the pathway driving FOP biology. In people with FOP, pathogenic variants in the ACVR1 gene abnormally activate ALK2, causing bone to form in muscles, tendons, ligaments and other soft tissue through heterotopic ossification, which can progressively restrict movement and cause significant disability.³

The approval was based on Cohort 1 of the Progress study, which evaluated zilurgisertib in patients aged 12 and older with FOP, with efficacy established on total new heterotopic ossification lesion volume over a 24-week double-blind period. At Week 24, mean total new lesion volume decreased by 3.2 cm3 in patients on zilurgisertib, compared with an increase of 24.6 cm3 in placebo-treated patients, and treatment effects were maintained through Week 48 of the open-label extension.³ The drug was generally well tolerated, with the most common adverse reactions being headache, arthralgia, upper respiratory tract infection, epistaxis and nausea; no adverse events led to discontinuation or dose reduction.

"Today marks an important milestone for people living with FOP, bringing a new treatment option to adult and pediatric patients living with this devastating disease," said Chris Peetz, chief executive officer of Mirum. "The approval of Atebrioz reflects what can be achieved when industry, researchers and patient communities work together."

With the approval, FDA also issued a Rare Pediatric Disease Priority Review Voucher to Incyte, which can be applied to a future drug application that would not otherwise qualify for priority review.³

Sources

1. FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata Eli Lilly and Company September 25, 2026, https://www.prnewswire.com/news-releases/fda-approves-lillys-olumiant-baricitinib-for-pediatric-patients-12-years-of-age-and-older-with-severe-alopecia-areata-302890631.html
2. U.S. FDA Approves AbbVie's Juvmo (tavapadon) for Parkinson's Disease AbbVie September 28, 2026, https://news.abbvie.com/2026-09-28-U-S-FDA-Approves-AbbVies-JUVMO-TM-tavapadon-for-Parkinsons-Disease
3. Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva Incyte September 25, 2026, https://investor.incyte.com/news-releases/news-release-details/mirum-pharmaceuticals-and-incyte-announce-us-fda-approval