Lily-Incyte pill for severe hair loss disease gets FDA approval

ORIGINAL SOURCE: Delaware Business Now

Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata.

“People with alopecia areata, dermatologists, and other healthcare providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease. Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities,” said Brett King, M.D., associate professor of dermatology at Yale School of Medicine and lead investigator. “I am so happy that adults with severe alopecia areata can now take

The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 late stage trials.

The drug came out of a long-running agreement between Lilly and Delaware-based Incyte, which developed the class of drugs that include Incyte’s blockbuster Jakafi blood cancer drug and Olumiant Incyte has collected payments for drug milestones with much larger Lilly handling development and marketing.

Regulators have required box label warnings on baricitinib, due to the possibility of severe side effects. That warning is also included on prescriptions of Olumiant used to treat the hair condition. The warnings are also in place when the drug is prescribed for the treatment of rheumatoid arthritis and have kept sales short of “blockbuster” status.

Alopecia areata was in the news when it was learned that actress Jada Pinkett Smith suffers from the condition. Her husbnd Will Smith slapped a host at the Academy Awards when he made a joke about his wife’s’ lack of hair.

Across the studies at 36 weeks, 17-22% of patients taking Olumiant 2-mg/day and 32-35% of patients taking Olumiant 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo. Additionally, 11-13% of patients taking Olumiant 2-mg/day and 24-26% of patients taking Olumiant 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo.

A small percentage of patients discontinued treatment due to adverse events (average of 2.2% across both studies. The U.S. FDA-approved a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events.

Lilly also expects regulatory decisions for OLUMIANT in AA in the European Union and Japan in 2022.