Lilly-Incyte Rheumatoid Arthritis Drug Is Rejected by U.S. FDA

  • Agency says additional studies needed on safety and efficacy
  • It’s unclear when the companies may resubmit the application

Eli Lilly & Co. and Incyte Corp.’s experimental rheumatoid arthritis drug was rejected by U.S. regulators, who said more information was needed on baricitinib’s safety and effectiveness before it is widely used by Americans.

The U.S. Food and Drug Administration asked for additional evidence about the best dose for treating patients with moderate-to-severe disease, the companies said Friday in a statement. The regulator also wants more data on potential safety concerns seen at different dose levels. 

The decision is a blow for a drug that analysts had projected would generate more than $1 billion in annual sales by 2020, according to data gathered by Bloomberg. While the FDA extended its review in January, many analysts and investors expected the medicine to win approval. European regulators cleared the drug for sale in February for patients who don’t respond to other treatments.

““We are disappointed with this action,” Christi Shaw, president of Lilly Bio-Medicines, said in the statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”

The timing for any resubmission of baricitinib’s marketing application will depend on future discussions with the FDA. The drug was first submitted to the FDA in January 2016. It was targeted to be sold under the brand name Olumiant.

Incyte is evaluating how the agency’s decision will affect its 2017 guidance for milestone payments and research and development expenses, and will issue an update on its first-quarter earnings conference call. Lilly, which bought the worldwide rights to baricitinib from Incyte in 2009, reaffirmed its financial guidance for 2017 and the remainder of the decade.

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