FDA stuns Lilly and Incyte with CRL for much-anticipated RA drug baricitinib

Even with a three-month extension, Eli Lilly was unable to quell FDA concerns about the safety risks of its highly anticipated rheumatoid arthritis drug baricitinib. Instead, it received a complete response letter saying more work must be done.

The Indianapolis-based drugmaker announced today that the FDA said it wants to see additional clinical data to get the doses right and to better characterize safety concerns for the once-daily oral medication for moderate-to-severe rheumatoid arthritis.

Eli Lilly said it and partner Incyte disagree with the FDA’s conclusions, indicating it might be able to speed the resubmission with more discussion. It also said it was not changing its financial guidance for the year, or its mid-term guidance for the rest of the decade as a result of the delay.   

"We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA," Christi Shaw, president of Lilly Bio-Medicines, said in a statement. "We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S."

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The CRL comes after the FDA in January extended the approval target action date on the once-daily oral JAK inhibitor so that Eli Lilly and Incyte could provide additional info. 

The partners had submitted baricitinib to the FDA in January 2016 with a wealth of positive data. Last year, the Indianapolis drugmaker bolstered its data collection with results from a long-term extension study that suggested baricitinib’s previously recorded positive effects could be maintained for at least 48 weeks. It had analysts projecting the med could reach $1.8 billion in sales by 2022. 

The decision means that Lilly's drug may now follow an new generation RA drug from Sanofi and Regeneron into the market. Their offering, an IL-6 inhibitor sarilumab that is also expected to reach blockbuster status, was also delayed last fall by a CRL tied to FDA concerns over manufacturing. Sanofi has since said the FDA has signed off on its fixes at the fill/finish facility in France, so an approval might be imminent.

The FDA decision is also a break for Pfizer’s Xeljanz, which preceded baricitinib into the field and last year won a label change for once-daily use. But Xeljanz has so far fallen short of expectations, last year generating just $927 million, far short of the $1.3 billion in rheumatoid arthritis sales analysts had predicted for it for last year.