DetailsCategory: Small MoleculesPublished on Sunday, 20 September 2020 11:23Hits: 231

Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic Dermatitis Medicine

INDIANAPOLIS, IN, USA I Septemer 18, 2020 I Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.

"Due to the limited treatment options currently available for adult patients with AD, we're excited to further explore baricitinib's potential benefit for patients,"said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "At Lilly, we aspire to elevate treatment standards for patients with dermatologic conditions. Today's CHMP opinion brings us closer to providing a new medicine for adults living with AD in Europe."

The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.

"Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option," said Prof. Thomas Bieber, M.D., Ph.D., M.D.R.A., Professor of Dermatology and Allergy, University Hospital in Bonn, Germany.

OLUMIANT is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

Lilly has exclusive worldwide development and commercialization rights for baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases under a license and collaboration agreement with Incyte.

Information on the previously approved EU OLUMIANT indication (Rheumatoid Arthritis) can be found here.

Indication and Usage for OLUMIANT (baricitinib) tablets (inthe 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 OLUMIANT

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. 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.1There 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.2OLUMIANT 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.1OLUMIANT is approved in more than 70 countries. OLUMIANT is developed by Lilly under license from Incyte Corporation.

About Atopic DermatitisAtopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.6

Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

About Lilly in DermatologyBy 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.

AboutEli Lilly and CompanyLilly 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. To learn more about Lilly, please visit us atlilly.comandlilly.com/newsroom.

About IncyteIncyteis aWilmington, 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 onIncyte, please visit Incyte.com and follow @Incyte.

1 Olumiant Prescribing Information, 2020.2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.4Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.5 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.6 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.7 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

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SOURCE: Eli Lilly

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CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis | Small Molecules | News...