The disease became a top news story after actor Will Smith slapped Academy Awards host Chris Rock after the comedian made a joke about Smith’s spouse who suffers from the disease. Incyte is based near Wilmington.
The study also showed that nearly 75% of those who responded to Olumiant achieved 90% scalp coverage at 52 weeks. The findings were announced at the American Academy of Dermatology Annual Meeting.
In February, the U.S. Food and Drug Administration (FDA) granted priority review for Olumiantin severe AA as a potential first-in-disease medicine. Lilly expects regulatory decisions in the U.S., European Union, and Japan in 2022.
Among patients who took Olumiant 4-mg, two out of five achieved significant scalp hair regrowth. Separately, more than two out of five patients saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair.
A smaller dose saw less hair regrowth.
The 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatology and Venereology Congress.
“Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. The disease affects people of all ages,” said Brett King, associate professor of dermatology at Yale School of Medicine and lead author of the analyses. “In 2022, Olumiant could become the first medicine ever approved to treat adults with alopecia areata. It’s remarkable that nearly 40% of patients on Olumiant 4-mg, all of whom started out with at least 50% scalp hair loss, experienced full or nearly full scalp hair coverage, and similar improvements were achieved among those patients with significant eyebrows or eyelashes involvement.”
In an evaluation of OLUMIANT 4-mg and 2-mg long-term safety, incidence rates of frequently reported adverse events up to 52 weeks were consistent with the 36-week, placebo-controlled period and included upper respiratory tract infection, headache, acne, urinary tract infection and increases in muscle-related blood markers. No new safety issues were raised.
In December 2009, Lilly and Incyte announced a worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
Olumiat has been touted as a “wonder drug” for the treatment of arthritis and other conditions. However, regulators have pointed to safety issues with LIlly dropping efforts to use the drug in the treatment of Lupus.
Sales of Olumiant reached $1.1 billion last year with Incyte earning royalty income.