FDA panel against higher dose of Lilly-Incyte arthritis drug

[April 24, 2018] By Tamara Mathias

(Reuters) - An arthritis drug developed by Eli Lilly & Co and Incyte Corp should not be approved at a 4-milligram dose, advisers to the U.S. FDA voted on Monday, in a setback to the drugmakers that were counting on the treatment as a future blockbuster.

The advisory committee to the U.S. Food and Drug Administration (FDA), however, voted in favor of approving a lower, 2 milligram (mg) dose of the drug, baricitinib, for the treatment of rheumatoid arthritis.

An approval of just the lower dose would severely limit the business opportunity for Lilly and Incyte , analysts have said.

Baricitinib, which is already approved in over 40 countries including in the European Union and Japan, is used largely as a 4 mg dose that is crucial for patients who do not respond to available therapies, Christi Shaw, the president of Lilly Bio-Medicines, said in an interview.

The vote comes a year after baricitinib was rejected by the FDA, which cited serious safety concerns.

The agency has continued to raise those concerns, particularly the risk of developing deadly blood clots.

The setback to Lilly and Incyte also comes as major drugs are already vying for a bigger slice of the lucrative market for rheumatoid arthritis drugs.

Pfizer's Xeljanz, AbbVie's Humira and Amgen's Enbrel are all approved to treat the disease.

While the advisory committee agreed that both the 2 mg and 4 mg doses of baricitinib were effective, panelists were divided on the question of the drug's safety.

The committee's recommendations, although not binding, are typically followed by the FDA.

A patient suffering from rheumatoid arthritis since the age of two described her struggles with the painful disease, telling the committee she had to resort to "eight aspirin a day for 10 years" back in the 1970s when treatment options were limited.

"There is nothing left for someone like me," the patient said, urging the committee to vote in favor of both doses.

The panel voted 10-to-5 in favor of approving the 2 mg dose, noting that the drug's benefits outweighed its risks.

The panel also voted by a similar margin against approving the 4 mg dose.

Lilly expects a decision from the FDA by the end of June, when it will announce further plans, Shaw said.

Incyte shares fell 3.6 percent to $65.71 in after-hours trading on Monday, while Lilly's stock dipped 1.2 percent to $80.20.

(Additional reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar)

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