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Look here, FDA: Eli Lilly touts Olumiant safety data for unapproved high dose

Eli Lilly is hoping new safety data presented this week will help it make the case with the FDA for a higher dose of rheumatoid arthritis med Olumiant. (Eli Lilly)

The path to success for Eli Lilly and Incyte’s rheumatoid arthritis med Olumiant in the U.S. has been a precarious one, with the FDA repeatedly knocking the drug’s larger dose. Could new long-term safety data—and a potential label expansion—help turn the tide in its fight against megablockbuster Humira?

Patients treated with 4-milligram doses of once-daily Olumiant over seven years showed roughly the same rate of adverse events as patients treated with placebo, according to safety data set to be presented Thursday at the Annual European Congress of Rheumatology in Madrid.

The study, which showed no significant difference in the rate of deep vein thrombosis (DVT) or pulmonary embolism for the drug’s unapproved 4-milligram dose, could help assuage FDA concerns that have so far kept the larger dose off the shelf.

In April 2018, Olumiant received an FDA nod to treat rheumatoid arthritis—but only for the drug’s 2-milligram dose and with a black box warning on its label for risk of infections, malignancy and thrombosis. The FDA knocked Lilly and Incyte for unclear safety and efficacy data in the higher dose, with an advisory committee voting to turn it down.

The new safety data for Olumiant’s 4-milligram dose showed only one significant difference over placebo: in herpes, where patients treated with Olumiant had a higher incidence rate than those taking a placebo. The drug’s 2-milligram dose, meanwhile, showed no significant difference in safety versus placebo in any category, Lilly said.

The new data could help steel Olumiant in its fight against megablockbuster Humira, particularly after European reviewers said Lilly’s drug matched the pricier Humira in terms of cost-effectiveness. England’s National Institute for Health and Care Excellence recommended Olumiant for placement on the country’s NHS in June 2017.

Olumiant isn’t the only member of the JAK inhibitor class that has struggled with safety concerns from the FDA. Pfizer, maker of rival drug Xeljanz, said in February it moved trial patients from a higher dose of the drug to a lower one after blood clot and death concerns popped up in the patient pool. Xeljanz sports a black box warning of its own for clotting and another JAK candidate from AbbVie saw sullied phase 3 results in rheumatoid arthritis after a reported death and pulmonary embolism.

Even if Olumiant’s newest safety data can’t sway the FDA, Lilly is hoping a possible new indication could eventually help push sales of the drug, which cleared $82 million in the first quarter.

Patients treated with 2-milligram and 4-milligram doses of Olumiant showed significant improvement in atopic dermatitis symptoms over placebo at the 16-week mark, according to data from two phase 3 studies presented at the World Congress of Dermatology meeting this week in Milan. Lotus Mallbris, Lilly’s VP of immunology development, said the drugmaker has high hopes in its newest indication pursuit.

“Atopic dermatitis is the psoriasis of 10 years ago,” she said. “There is a huge unmet need, there is opportunity for innovation and patients deserve new options.”

The two studies, which included more than 1,200 patients, are the first of seven planned for Olumiant in atopic dermatitis, Lilly said, which could help the drug become the first oral treatment approved in that indication.