Eli Lilly revs up immunology engine as Olumiant cruises toward coveted alopecia green light

Immunology may be the youngest of Eli Lilly’s business units, but the Indianapolis-based pharma expects to have skin in the game for years to come.

When Lilly carved out its immunology unit last year, the company made a “long-term commitment” to the field, operating under the assumption it had a portfolio of products “not just today, but at least for the coming decade or decades,” Patrik Jonsson, the company’s immunology president and president of Lilly USA, said during a recent sit-down in New York.

Much of the immunology buzz at Lilly currently revolves around three prospects: There’s rheumatoid arthritis and COVID-19 med Olumiant, which is closing in on a green light in alopecia areata; mirikizumab, meanwhile, is pursuing a nod in ulcerative colitis, where it has the potential to be the first IL-23 inhibitor approved for a disease where “huge unmet need” remains, Jonsson explained; Finally, lebrikizumab is tuning its pitch in atopic dermatitis, where the antibody could be “very competitive,” the executive said.

Olumiant, for its part, represents the nearest potential immunology launch. The company filed for approval in alopecia at the end of 2021 and, assuming the drug passes muster at the FDA, expects to launch in the second half of 2022, Jonsson said.

Back in March, Lilly and its partner Incyte touted Olumiant’s impressive hair regrowth potential at the American Academy of Dermatology’s annual meeting—which, as an aside, took place the same weekend as Will Smith’s infamous Oscar’s slap. Among adults with severe alopecia areata on Olumiant, nearly 75% of patients who responded to a 4-mg dose of Olumiant achieved 90% scalp hair coverage at the 52-week mark, the company reported at the time.

Those results are nothing short of “remarkable,” Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly, told Fierce Pharma earlier this year. Armed with a year’s worth of data from two phase 3 trials, Lilly expects to win approval for Olumiant in alopecia areata in the U.S., Europe and Japan before the year is out, she added.

Meanwhile, Lilly already has a strong dermatology network in place for the launch, Jonsson explained. The company’s Taltz, which is approved in plaque psoriasis, psoriatic arthritis and ankylosing spondylitis, pulled down $2.2 billion in full-year sales last year, Lilly said in early 2022.

Alopecia areata “fits very well into our current infrastructure,” Jonsson said. “We have the expertise in dermatology both development-wise … and also from a customer-facing perspective,” he explained.

Olumiant’s alopecia bid comes as JAK inhibitors at large fall under class-wide safety scrutiny. Still, given the unmet need in alopecia—where current treatment is restricted to cosmetic stopgaps like wigs and false eyelashes—Lilly figures regulators will view the med’s risk-benefit profile favorably, Jonsson said.

Aside from Taltz, Olumiant makes up the other main half of Lilly’s current immunology stable. In its present indications, the drug generated about $1.1 billion in full-year 2021 sales. The company also picked up Qbrexza, a medicated cloth approved for uncontrolled excessive underarm sweating, in its 2020 Dermira buyout, which also yielded eczema prospect lebrikizumab.

One aspect of Olumiant’s alopecia launch that will be crucial? Education, Jonsson said. Lilly will have its work cut out spreading the word that alopecia areata is a disease warranting pharmaceutical treatment, rather than a cosmetic concern alone. In some ways, the conversation will resemble that taking place around obesity now, where companies like Lilly and Novo Nordisk are working to eliminate stigma.

The situation also echoes Lilly’s experience in depression, Jonsson said. When the company moved into that space three decades ago, there was “a lot of stigma” surrounding mental health, he explained. While alopecia is obviously completely different, there’s plenty of overlap in terms of the need to “destigmatized a disease,” Jonsson said.

Although Lilly hasn't explicitly laid out tentative approval timelines for its other two drugs, it said it filed mirikizumab last month and plans to submit lebrikizumab by the end of the year. Based on a potential 12-month review, those approvals could come sometime in 2023.

With the potential to launch Olumiant in alopecia in 2022 and two other candidates next year, “I don’t think we’ve ever had a more exciting time in the space of immunology than we’re having right now,” Jonsson said.