Lilly’s Olumiant Gets Breakthrough Therapy Designation for Alopecia


The U.S. Food and Drug Administration (FDA) granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata (AA). AA is an autoimmune disease that can cause hair loss on the scalp, face and other areas of the body.

Baricitinib is currently approved in the U.S. under the brand name Olumiant for adults with moderately to severely active rheumatoid arthritis who have an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. It is a once-daily, oral JAK inhibitor.

Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions where early clinical evidence shows the drug might demonstrate significant improvement over already available therapies.

The Breakthrough Therapy designation in this case was built on the positive Phase II trial results from Lilly’s adaptive Phase II/III BRAVE-AA1 trial that compared baricitinib to placebo in adults with AA. In the Phase II portion at Week 36, there were no new safety signals. Based on that data, the Phase III part of the trial and an additional Phase III double-blind study dubbed BRAVE-AA2 are currently running to test the efficacy and safety of two doses, 2 mg and 4 mg, of the drug compared to placebo.

“Patients with AA currently do not have any FDA-approved treatment options available to them,” said Lotus Mallbris, 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 patients.”

Last week, Lilly announced that it and AbCellera had inked a deal to co-develop antibody products to treat and prevent COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The partnership will leverage AbCellera’s rapid pandemic response platform, which was developed under The Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) Program and Lilly’s global abilities for quickly developing, manufacturing and distributing therapeutic antibodies.

Within a single week after receiving a blood sample from one of the first U.S. patients to recover from COVID-19, British Columbia-based AbCellera screened more than 5 million immune cells in search of ones that produced functional antibodies that helps the patients neutralize the virus and recover from COVID-19. To date, AbCellera has identified more than 500 unique fully human antibody sequences. The next step is screening them to find the ones most effective at neutralizing the virus.

On the same day, the FDAgrantedLilly’s Jardiance (empagliflozin) Fast Track designation to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease. Jardiance is approved to lower blood sugar in adults with type 2 diabetes and to decrease the risk of cardiovascular death in adults with type 2 diabetes who have cardiovascular disease.

“We recognize the close link between the health of the heart, kidneys and metabolic system, and we have committed to a broad clinical development program assessing the cardiorenal metabolic benefits of Jardiance,” said Jeff Emmick, vice president, Product Development, Lilly. “The Fast Track designation from the FDA is an important step in evaluating the potential of Jardiance to enhance care for those with chronic kidney disease.”


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