Lilly's Olumiant posts trial win in autoimmune hair loss, setting up potential first-in-class FDA nod

Eli Lilly is counting on its new meds—including rheumatoid arthritis drug Olumiant—to drive growth in the years to come. With a new trial win in the autoimmune disease alopecia areata, which causes hair loss, the med might have an entirely new field to itself. 

Lilly said that baricitinib (approved in RA as Olumiant) posted positive phase 3 data in alopecia areata, where no other meds have scored FDA approvals. Lilly didn’t share detailed data, saying only that the medicine bested a placebo in meeting the primary endpoint of hair regrowth in patients with severe disease. The company plans to present detailed results at an upcoming medical conference. 

The trial included 546 patients in the U.S. and eight other countries. It was the first phase 3 trial to turn in positive results in alopecia areata, Lilly said. The company expects results from another trial of baricitinib in alopecia areata in the coming months. 

Last year, the FDA granted breakthrough designation to baricitinib in the disease, signifying the FDA sees promise for the therapy in an area where patients are underserved. Alopecia areata can cause hair loss on the scalp, face and other areas of the body.

It's “not a cosmetic condition,” Lotus Mallbris, Lilly VP of immunology development, said in a statement. It’s “a devastating autoimmune disease that can have significant psychological effects." 

Lilly is “working closely with the FDA and plans to submit baricitinib for approval in the U.S.” after reviewing data from the other ongoing study, Mallbris told Fierce Pharma. In the meantime, the company is “encouraged by the results ... in support of a potential path for baricitinib to become the first FDA-approved treatment for AA.”  

The results are “very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata," Yale School of Medicine associate professor of dermatology Brett King added in a statement. 

RELATED: Eli Lilly, Incyte's Olumiant notches another atopic dermatitis win. But can it fight Dupixent? 

Baricitinib is approved in the U.S. and other countries to treat rheumatoid arthritis, as well as in Europe and Japan to treat certain patients with atopic dermatitis. In the U.S., Lilly has submitted the drug to the FDA in atopic dermatitis following a phase 3 trial win.

The phase 3 trial success in alopecia areata follows another win for the drug in COVID-19. After positive trial results, the drug scored an emergency use authorization in November in combination with Gilead Sciences’ Veklury in patients who are hospitalized and require oxygen. 

The company is also testing baricitinib in systematic lupus erythematosus and juvenile idiopathic arthritis. 

RELATED: Lilly scores FDA emergency authorization for Olumiant in COVID-19, its 2nd therapeutic option 

Olumaint is among a group of new meds Lilly is counting on to propel growth in the coming years. Last year, the drug generated $639 million worldwide, a 50% leap from 2019. In total, all of Lilly’s new drugs generated about half of the company's fourth-quarter sales.