Lilly to seek industry-first FDA nod in autoimmune hair loss after Olumiant's 2nd trial win

Eli Lilly last month trumpeted top-line results showing its rheumatoid arthritis med Olumiant could trigger hair regrowth in the autoimmune disease alopecia areata, where no med has ever won an FDA green light. Armed with positive data from a second late-stage trial, the drugmaker now has an approval filing in its sights.

In a second phase 3 study, a once-daily dose of baricitinib—approved in rheumatoid arthritis as Olumiant—bested placebo at stimulating hair regrowth in patients with severe alopecia areata (AA), Lilly said this week. With those data in hand, Lilly plans to submit the drug for FDA approval in the second half of the year.

At the 36-week mark, 35% of patients on a daily regimen of baricitinib 4 mg reached at least 80% of scalp hair coverage, versus 22% in the 2 mg arm. Only 5% of patients in the placebo cohort hit the hair regrowth target. 

Those results line up with top-line data from a separate trial that Lilly reported in March. In that study, 33% of patients on the 4 mg dose achieved 80% scalp hair coverage at week 36, as did 17% of patients on 2 mg baricitinib. Just 3% of patients in the control group reached the target.

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In both studies, the drug's safety was on par with baricitinib in rheumatoid arthritis and atopic dermatitis, Lilly said. Upper respiratory tract infections, headache and acne comprised the most common side effects.

Safety will certainly be on the FDA's radar when it reviews Lilly's application. Baricitinib is a member of the JAK inhibitor class of medicines, which have come under increased scrutiny following a post-marketing study failure for Pfizer's Xeljanz earlier this year. 

Since that failure, the FDA has opted to push back decisions on Olumiant, plus Pfizer’s investigational abrocitinib, in moderate-to-severe atopic dermatitis by three months. AbbVie's Rinvoq has been hit with a pair of FDA delays, as well.

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Still, there's clearly a need for an approved AA drug, and Lilly could soon have the field all to itself. 

"There is a pressing need for approved treatment options for people suffering from alopecia areata," Maryanne Senna, M.D., a dermatologist and one of the trial's investigators, said in a statement. She noted that the topical treatments and steroids currently on tap are of little help to most AA patients. 

Recognizing that need, the FDA last year granted breakthrough designation to baricitinib in AA, which can cause patchy hair loss on the scalp, face and other areas of the body. 

In 2020, Olumiant ginned up $639 million worldwide, marking a whopping 50% increase over 2019. It ranks among a suite of new meds Lilly is counting on to drive growth in the coming years.