Yahoo Finance Lilly (LLY), Incyte's Olumiant Gets FDA Nod for Alopecia Areata
Eli Lilly LLY and partner Incyte INCY announced that the FDA has granted approval to their oral JAK inhibitor, Olumiant (baricitinib) for treating adults with severe alopecia areata (“AA”). This autoimmune disorder results in non-scarring hair loss.
Until now there were no FDA-approved systemic treatments for AA. Systemic treatments are treatments that target the entire body and not any specific area. Olumiant is the first-ever FDA-approved systemic treatment for alopecia areata patients. Olumiant will now be available for adults with AA as a 4-mg, 2-mg and 1-mg once-daily tablet.
Lilly’s shares have risen 5.5% this year so far compared with the industry’s increase of 1%.
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Olumiant’s approval for AA was based on data from two phase III studies, BRAVE-AA1 and BRAVE-AA2, which showed that Olumiant significantly improved hair re-growth. Across the two studies, 17-22% of patients taking Olumiant 2-mg/day and 32-35% of those taking Olumiant 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo, at 36 weeks. Patients with significant eyebrow and eyelash hair loss taking Olumiant 4-mg daily also witnessed improvements in eyebrow and eyelash coverage at 36 weeks
Last month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approval of Olumiant (baricitinib) for AA. A decision from the European Commission is expected in the coming months.
Besides AA, Olumiant is approved to treat rheumatoid arthritis (RA) and COVID-19 in certain hospitalized adults requiring various degrees of oxygen support. Olumiant is also approved in Europe and Japan for atopic dermatitis while it is under review in the United States for the same indication.
The drug generated sales of $255.6 million for Lilly in the first quarter of 2022, up 32% on a year-over-year basis.
Some other popular JAK inhibitor medicines available are AbbVie’s ABBV Rinvoq (upadacitinib) and Pfizer’s PFE Xeljanz.
AbbVie’s Rinvoq is approved for RA, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. AbbVie expects Rinvoq to be its key top-line driver when generics of its blockbuster immunology medicine Humira are launched in the United States next year.
Rinvoq registered sales of $465 million in the first quarter, up 57.3% year over year.
Pfizer’s Xeljanz is approved for RA, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis. Xeljanz sales declined 29% to $372 million in the first quarter.
However, neither Rinvoq nor Xeljanz are approved to treat AA.
Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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