Eli Lilly has been hustling to snag the industry’s first alopecia areata (AA) nod with JAK inhibitor Olumiant for the better part of a year. Now, the Indianapolis-based pharma is making another plug for Olumiant’s hair loss potential with four more months of data showing its med aced hair regrowth metrics in nearly half of patients treated with a higher dose.
Among adults with severe AA on Lilly’s Olumiant, nearly 75% of patients who responded to a 4-mg dose achieved 90% scalp hair coverage at the 52-week mark, Lilly said Saturday. Armed with a win in the underserved autoimmune disease, the company expects regulatory decisions on Olumiant before the year is out in the U.S., Europe and Japan, Lilly and its partner Incyte said at the American Academy of Dermatology’s 2022 annual meeting.
Taking a closer look at the results from Lilly’s two phase 3 trials, BRAVE-AA1 and BRAVE-AA2, 39% of patients on Olumiant 4-mg experienced “significant” scalp hair regrowth, as measured by the Severity of Alopecia Tool (SALT), Lilly said. The company defined significant regrowth as a SALT score of up to 20, which translates to 80% or more scalp hair coverage, Lilly explained. Among that same set of patients, roughly 74% achieved 90% scalp coverage at the end of one year.
Just 22.6% of alopecia patients on the 2-mg dose of Olumiant saw “significant” scalp hair regrowth. About two thirds of those patients hit 90% hair coverage.
The separate doses performed similarly when it came to eyebrow and eyelash hair regrowth. More than two out of five patients on Olumiant 4 mg who entered the study with “significant” eyebrow and eyelash hair loss “saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair,” Lilly said.
For those on the 2-mg dose, more than 1 in 5 and 1 in 4 patients, respectively, enjoyed full eyebrow and eyelash regrowth, or regrowth with minimal gaps, the company added.
The new 52-week readout builds on 36-week data Lilly rolled out between last March and April. Following last year’s top-line win, Lilly said it planned to submit Olumiant for FDA approval in AA in the second half of the year. Lilly has since sent off its application to the FDA, the company said (PDF) in its 2021 annual report.
Those results are nothing short of “remarkable,” Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Eli Lilly, said in a recent interview. Armed with a full year’s worth of data from BRAVE-AA1 and BRAVE-AA2, Lilly expects to win approval, if not launch, in the U.S., Europe and Japan in 2022, Mallbris said.
If cleared in AA, Olumiant would bear the distinction of being the first therapy specifically approved to treat the autoimmune disease. Currently, patients’ disease is often treated with cosmetic solutions such as wigs or false eyebrows and eyelashes, Mallbris explained. Others rely on off-label therapies such as uncomfortable corticosteroid injections in the scalp.
Meanwhile, Olumiant would not only be the first bespoke treatment option for AA–it would also be more convenient than injectable treatments thanks to its simple oral dosing, she added.
If Olumiant breaks into AA, Lilly will have its work cut out convincing doctors and patients that alopecia is a disease that warrants pharmaceutical treatment. Given the current dearth of therapeutic options, many AA patients have been “lost in clinical care,” Mallbris explained. The current pathway for patients living with AA can be “very challenging,” to hear Mallbris tell it, with many avoiding treatment altogether because of a sense of “hopelessness.”
Because so many AA patients have fallen through the cracks, Lilly’s estimates on the total disease population are “rough,” Mallbris admitted. Lilly says approximately 147 million people worldwide have or will have AA, with between 700,000 to 900,000 suffering from severe disease.
Meanwhile, safety in Lilly’s two phase 3 studies was on par with Olumiant’s known profile, Mallbris said. Baricitinib is a member of the JAK inhibitor class, which has come under intense safety scrutiny in recent months following a post-marketing study of Pfizer’s Xeljanz. Nevertheless, Lilly believes it has the data to show its med is not only effective, but safe.