FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata

INDIANAPOLIS, IN, USA I June 13, 2022 I Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.1 The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day. Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day.1 OLUMIANT is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.1

"People with alopecia areata, dermatologists and other healthcare providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease. Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities," 2-4 said Brett King, M.D., Ph.D., F.A.A.D., associate professor of dermatology at Yale School of Medicine and lead investigator of the BRAVE-AA program. "I am so happy that adults with severe alopecia areata can now take OLUMIANT, a once-daily pill. The results of clinical trials are remarkable, as one in five adults taking OLUMIANT 2-mg/day and one in three taking OLUMIANT 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking OLUMIANT 4-mg/day with substantial eyebrow or eyelash hair loss."1

The approval was based on Lilly's BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase 3 AA clinical trial program completed to date,5-7 evaluating the efficacy and safety of OLUMIANT in 1,200 adult patients with severe AA (≥50% scalp hair loss as defined by a Severity of Alopecia Tool (SALT) score ≥50).1 Across the studies at 36 weeks, 17-22% of patients taking OLUMIANT 2-mg/day and 32-35% of patients taking OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.1 Additionally, 11-13% of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for OLUMIANT 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2.1

Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.1 

The BRAVE-AA clinical program evaluated the safety profile of OLUMIANT.1 Few patients discontinued treatment due to adverse events (average of 2.2% across both studies) in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity.8 The most commonly reported adverse reactions (≥1%) were upper respiratory tract infections, headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, elevated liver enzyme levels, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infection, low red blood cell counts, low white blood cell counts, abdominal pain, shingles and weight increase.1 The U.S. FDA-approved labeling for OLUMIANT includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.1 See below for full Important Safety Information.

"Today marks a milestone with the first-ever FDA-approved systemic treatment for alopecia areata patients, who face significant challenges every day including limited public knowledge about the disease, a lack of treatment options and social stigma,"9 said Nicole Friedland, president and chief executive officer, National Alopecia Areata Foundation (NAAF). "The approval of OLUMIANT can spark hope for many patients and encourage new treatment conversations with their doctors. NAAF wants more choices for our patient community and with the approval of OLUMIANT, there are now new treatment expectations being established in alopecia areata care."

Lilly is committed to ensuring patients have access to much-needed medicines and is working with insurers to do so. Through the OLUMIANT TogetherTM support program, Lilly offers a savings card for eligible commercially insured patients* to help with out-of-pocket costs where they pay as little as $5/month if covered by their insurance provider or $25/month if not covered by their plan. The savings card is available at specialty pharmacies, and in the coming days will be available for download on OLUMIANT.com. 

"There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved systemic medicine. In fact, a study published in 2017 of 1,083 people with AA showed that nearly 80 percent were unsatisfied with their treatment options,"10 said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. "Our mission is to make life better for people living with debilitating immune-mediated diseases. OLUMIANT's approval is a historic moment, and we're delighted about what it can mean for adults with severe alopecia areata."  

Learn more about OLUMIANT; view the 2-mg and 4-mg product photos and brand logo.

OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly and is available through specialty pharmacies nationwide. Lilly also expects regulatory decisions for OLUMIANT in AA in the European Union and Japan in 2022.

About BRAVE-AA1 and BRAVE-AA2
In these double-blind, placebo-controlled Phase 3 trials, 1,200 patients with severe AA were randomized to receive once-daily OLUMIANT 2-mg, OLUMIANT 4-mg or placebo.

  • The primary endpoint was the proportion of patients achieving SALT ≤20 (i.e., 80% or more scalp hair coverage) at Week 36.1 Across both studies, 17-22% of patients taking OLUMIANT 2-mg/day (BRAVE-AA1=22% [n=40/184]; BRAVE-AA2=17% [n=27/156]) and 32-35% of patients treated with OLUMIANT 4-mg/day (BRAVE-AA1=35% [n=99/281]; BRAVE-AA2=32% [n=76/234]) achieved 80% or more scalp hair coverage, compared to 5% (n=10/189) and 3% (n=4/156) of patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (p≤0.001 for all comparisons to placebo).
  • Additionally, 11-13% of patients taking OLUMIANT 2-mg/day (BRAVE-AA1=13% [n=23/184]; BRAVE-AA2=11% [n=17/156]) and 24-26% of patients taking OLUMIANT 4-mg/day (BRAVE-AA1=26% [n=73/281]; BRAVE-AA2=24% [n=55/234]) achieved 90% or more hair coverage, compared to 4% (n=7/189) and 1% (n=1/156) of patients taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (p<=0.001 for OLUMIANT 4-mg/day comparisons to placebo; p<=0.01 for OLUMIANT 2-mg/day comparison to placebo in BRAVE-AA1).1,8 SALT 10 (90% hair coverage) results for OLUMIANT 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2.8

Indications and Usage for OLUMIANT (baricitinib) tablets (in the United States)

OLUMIANT is indicated for the treatment of adult patients with severe alopecia areata.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

OLUMIANT is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

About OLUMIANT®
OLUMIANT, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved in the U.S. and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis. FDA approval was granted for OLUMIANT for the treatment of certain hospitalized adult patients with COVD-19 in May 2022. Marketing authorization for OLUMIANT in COVID-19 has been granted in six other countries including Japan and Switzerland. The U.S. FDA-approved labeling for OLUMIANT includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information here.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of OLUMIANT and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

About Lilly
Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram, Twitter and LinkedIn. P-LLY

About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

OLUMIANT® and OLUMIANT TogetherTM are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Other trademarks listed are the property of their respective owners.

  1. Olumiant. Prescribing Information. Lilly USA, LLC.
  2. Pratt CH, King LE Jr, Messenger AG, et al. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011.
  3. Wang EHC, Sallee BN, Tejeda CI, et al. Janus kinase inhibitors for treatment of alopecia areata. J Invest Dermatol. 2018;138:1911-1916.
  4. Strazzulla LC, Wang EHC, Avila L, et al. Alopecia areata: disease characteristics, clinical evaluation, and new perspectives on pathogenesis. J Am Acad Dermatol. 2018;78:1-12.
  5. Pfizer Inc. (2018, November - 2022, February). PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3). Identifier NCT03732807. https://clinicaltrials.gov/ct2/show/results/NCT03732807 
  6. Concert Pharmaceuticals (2020, August). A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1) (THRIVE-AA1). Identifier NCT04797650. https://clinicaltrials.gov/ct2/show/NCT04797650
  7. Concert Pharmaceuticals (2021, March). A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA2) (THRIVE-AA2). Identifier NCT04518995. https://clinicaltrials.gov/ct2/show/NCT04518995.
  8. Data on file. Lilly USA, LLC. DOF-BA-US-0075.
  9. U.S. Food & Drug Administration. The voice of the patient: a series of reports from the U.S. Food and Drug Administration's (FDA) patient-focused drug development initiative: Alopecia Areata. Meeting date: September 11, 2017; report date: 2018. https://www.fda.gov/media/112100/download. Accessed 18 March 2022.
  10. Hussain ST, Mostaghimi A, Barr PJ, et al. Utilization of mental health resources and complementary and alternative therapies for alopecia areata: a U.S. survey. Int J Trichology. 2017;9(4):160-164.

SOURCE: Eli Lilly; Incyte

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