Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

Adults with severe alopecia areata (AA) who took OLUMIANT® (baricitinib) achieved significant scalp, eyelash and eyebrow hair regrowth and nearly 75% of those who responded to OLUMIANT 4-mg achieved 90% scalp coverage at 52 weeks, Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today at the American Academy of Dermatology (AAD) Annual Meeting. In February 2022, the U.S. Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. Lilly expects regulatory decisions in the U.S., European Union and Japan in 2022.

In the pooled 52-week analysis, patients at baseline had a mean Severity of Alopecia Tool (SALT) score of 85.5 (85.5% scalp hair loss, or 14.5% scalp hair coverage); severe AA is defined as having a SALT score ≥50 (≥50% scalp hair loss). At baseline, 69.4% and 57.9% had significant eyebrow and eyelash hair loss, respectively, as defined by Clinician-Reported Outcome (ClinRO) scores ≥2. Patients’ average age was 37.6 years, with hair loss starting around age 25 and a mean of 12.2 years since symptom onset.

Among patients who took OLUMIANT 4-mg, two out of five (39.0%, n=201/515) achieved significant scalp hair regrowth, defined as a SALT score ≤20, or 80% or more scalp hair coverage, and nearly three out of four of those patients (74.1%, n=149/201) also achieved a SALT score ≤10, or 90% hair coverage, at 52 weeks. Separately, more than two out of five patients with ClinRO baseline scores ≥2 (eyebrow: 44.1%, n=154/349; eyelash: 45.3%, n=139/307) saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair.

Among patients who took OLUMIANT 2-mg, more than one out of five (22.6%, n=77/340) achieved significant scalp hair regrowth and two out of three of those patients (67.5%, n=52/77) achieved 90% or more hair coverage at 52 weeks. Separately, more than one in five and one in four patients, respectively (eyebrow: 22.9%, n=55/240; eyelash: 25.5%, n=51/200), saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair.

These 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published today in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatology and Venereology (EADV) Congress.

“Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. The disease affects people of all ages,” said Brett King, M.D., Ph.D., F.A.A.D., associate professor of dermatology at Yale School of Medicine and lead author of these analyses. “In 2022, OLUMIANT could become the first medicine ever approved to treat adults with alopecia areata. It’s remarkable that nearly 40% of patients on OLUMIANT 4-mg, all of whom started out with at least 50% scalp hair loss, experienced full or nearly full scalp hair coverage, and similar improvements were achieved among those patients with significant eyebrows or eyelashes involvement.”

“OLUMIANT’s long-term efficacy data reveal significant regrowth of scalp, eyelash and eyebrow hair and we’re delighted by what these results can mean for patients. Our alopecia areata safety data adds further evidence to one of the largest and longest sets of safety data in the JAK inhibitor class, including nine years and 19,000 patient years across our program,” said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly. “We’re excited OLUMIANT may be a potential first-in-disease medicine approved this year for adults with severe alopecia areata.”

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 and is approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. To date, more than 343,000 patients have been treated with OLUMIANT worldwide across approved indications. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for OLUMIANT in multiple countries. 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. OLUMIANT is also being investigated in COVID-19, alopecia areata (AA) and juvenile idiopathic arthritis (JIA).

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.

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

OLUMIANT® (baricitinib) 2 mg 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) antagonist therapies. Limitation 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.

About Eli Lilly and Company

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

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.

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