– Baricitinib met primary endpoint of hair regrowth across both dosing regimens
– There are currently no FDA-approved treatments for AA
INDIANAPOLIS, IN, USA I March 3, 2021 I Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. This classification 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). There are currently no FDA-approved treatments for AA.
“These positive results are very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata,” said Brett King, M.D., Ph.D., associate professor of Dermatology at Yale School of Medicine. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”
This multicenter, randomized, double-blind, placebo-controlled study included 546 adults with a Severity of Alopecia Tool (SALT) score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. The study included a diverse patient population from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S.
Safety outcomes of baricitinib in BRAVE-AA2 were consistent with its established safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD). No deaths, major adverse cardiovascular events (MACE) or venous thromboembolic events (VTEs) were reported in the study.
BRAVE-AA2 is the first Phase 3 study with positive results in patients with AA. Data from an additional Phase 3 study of baricitinib in AA will be available in the first half of this year. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. AA is the second potential treatment indication in dermatology for baricitinib after AD.
“For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. They lose much more than just hair,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata.”
“Significant unmet need exists in the treatment of alopecia areata,” said Abby Ellison, research director at the National Alopecia Areata Foundation (NAAF). “We appreciate Lilly’s important work in this area and are excited that these data could bring us closer to a potential new treatment option for patients.”
Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. Baricitinib is also being investigated in systematic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA) and COVID-19.
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.
Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.
BA HCP ISI 09JUL2020
About OLUMIANT®
OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, 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 baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
About Alopecia Areata
Alopecia Areata (AA) is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. 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 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 at lilly.com and lilly.com/newsroom. 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.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with rheumatoid arthritis and atopic dermatitis and as a potential treatment for patients with alopecia areata and other conditions and reflects Lilly’s and Incyte’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s and Incyte’s most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.
SOURCE: Incyte
Post Views: 418
– Baricitinib met primary endpoint of hair regrowth across both dosing regimens
– There are currently no FDA-approved treatments for AA
INDIANAPOLIS, IN, USA I March 3, 2021 I Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. This classification 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). There are currently no FDA-approved treatments for AA.
“These positive results are very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata,” said Brett King, M.D., Ph.D., associate professor of Dermatology at Yale School of Medicine. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”
This multicenter, randomized, double-blind, placebo-controlled study included 546 adults with a Severity of Alopecia Tool (SALT) score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. The study included a diverse patient population from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S.
Safety outcomes of baricitinib in BRAVE-AA2 were consistent with its established safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD). No deaths, major adverse cardiovascular events (MACE) or venous thromboembolic events (VTEs) were reported in the study.
BRAVE-AA2 is the first Phase 3 study with positive results in patients with AA. Data from an additional Phase 3 study of baricitinib in AA will be available in the first half of this year. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. AA is the second potential treatment indication in dermatology for baricitinib after AD.
“For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. They lose much more than just hair,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata.”
“Significant unmet need exists in the treatment of alopecia areata,” said Abby Ellison, research director at the National Alopecia Areata Foundation (NAAF). “We appreciate Lilly’s important work in this area and are excited that these data could bring us closer to a potential new treatment option for patients.”
Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. Baricitinib is also being investigated in systematic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA) and COVID-19.
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.
Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.
BA HCP ISI 09JUL2020
About OLUMIANT®
OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, 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 baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
About Alopecia Areata
Alopecia Areata (AA) is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. 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 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 at lilly.com and lilly.com/newsroom. 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.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with rheumatoid arthritis and atopic dermatitis and as a potential treatment for patients with alopecia areata and other conditions and reflects Lilly’s and Incyte’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s and Incyte’s most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.
SOURCE: Incyte
Post Views: 418
