Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata

Recognition reinforces baricitinib's potential to be the first FDA-approved medicine for individuals living with alopecia areata

INDIANAPOLIS, IN, USA I March 16, 2020 I Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata (AA), an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body. The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s).  

"Patients with AA currently do not have any FDA-approved treatment options available to them," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "AA not only causes hair loss but also may be a psychosocial burden for people living with this disease. At Lilly, we aspire to create new medicines that can give hope to patients. We look forward to working with the FDA to further explore baricitinib's potential to become the first approved treatment option for these individuals."

The FDA Breakthrough Therapy designation is based on the positive Phase 2 results of Lilly's adaptive Phase 2/3 study BRAVE-AA1, which evaluated treatment with baricitinib versus placebo in adult patients with AA. In the Phase 2 portion of the BRAVE-AA1 study up to Week 36, there were no new safety signals with no serious adverse events reported. The reported treatment-emergent adverse events (TEAEs) were mild or moderate and the most common included upper respiratory tract infections, nasopharyngitis and acne.

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 double-blind study (BRAVE-AA2), are currently assessing the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.

"There are millions of people around the world affected by and living with AA," said Dory Kranz, president and CEO of the National Alopecia Areata Foundation. "We're encouraged by baricitinib's potential to be one of the first FDA-approved medicines to treat AA."

Baricitinib is currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). More than 100,000 patients have experience using baricitinib, which is approved in over 65 countries including the U.S., member states of the EU and Japan. It is marketed as OLUMIANT®.

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

About OLUMIANT®
OLUMIANT is a once-daily, oral JAK inhibitor approved in more than 65 countries for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.ii OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.i 

About Alopecia Areata
Alopecia areata (AA) is a common autoimmune skin disease which results in hair loss on the scalp, face and sometimes other areas of the body. AA often first appears during childhood and can be different for everyone who has it. People of all ages, males/females and all ethnic groups can develop AA.

About Lilly in Dermatology
By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly and Company 
Lilly is a global healthcare 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. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels

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.  P-LLY

SOURCE: Eli Lilly

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