Posted by Michael Wonder on 19 Apr 2018
FDA staff raises safety concerns over Lilly/Incyte arthritis drug
19 April 2018 - An experimental rheumatoid arthritis drug developed by Eli Lilly and Incyte poses serious risks of deadly blood clots at higher doses, U.S. FDA staff said on Thursday, the latest setback to a treatment regulators declined to approve last year.
New data provided by the companies in a resubmission of their marketing application did not substantially alter information from the original, the staffers said.
“At this point, approval in the U.S. is in jeopardy,” Hilliard Lyons analyst Kurt Kemper told Reuters, adding that the review was much harsher than he had expected.
