(Reuters) -Eli Lilly and Co said on Friday it expects the U.S. Food and Drug Administration to decline the approval of expanded use of its rheumatoid arthritis drug as a treatment for adults with moderate-to-severe eczema.
“At this point, the company does not have alignment with the FDA on the indicated population,” the drugmaker said.
Olumiant, discovered by Incyte Corp and licensed to Lilly, belongs to a class of drugs called JAK inhibitors, which came under regulatory scrutiny after Pfizer’s arthritis drug Xeljanz showed an increased risk of serious heart-related problems and cancer in a February trial.
The path to approval for the drug has been arduous, with the FDA extending its review timeline https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-provide-update-supplemental-new-drug repeatedly.
AbbVie’s rival eczema drug, Rinvoq, also faced similar regulatory hurdles before being finally approved by the FDA earlier this month, as well as Pfizer’s Cibinqo.
“While not specified by the company, we wonder if the FDA may be looking to limit the use of the product (Olumiant) to an even smaller subset of patients than what Rinvoq and Cibinqo were approved for,” Mizuho analyst Vamil Divan said in a client note.
Lilly also said it has decided to discontinue its program for testing use of Olumiant in autoimmune disease lupus, based on early results from two late-stage trials.
The decision would adversely affect Lilly which continues to bet on upcoming regulatory decisions on the drug for treating COVID-19 for certain hospitalized patients and severe alopecia areata, a type of hair loss.
In the United States, the drug is already authorized for emergency use in hospitalized adults with COVID-19 and children aged two or older requiring supplemental oxygen or mechanical ventilation. Lilly awaits Olumiant’s full approval in certain hospitalized COVID-19 patients, with an anticipated regulatory action in the second quarter.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini Ganguli)