FDA staff raises safety concerns over Lilly/Incyte arthritis drug
(Reuters) – U.S. Food and Drug Administration staff flagged concerns on Thursday about potentially fatal blood clots from higher doses of a rheumatoid arthritis drug developed by Eli Lilly and Co and Incyte Corp, a fresh setback after regulators declined to approve the treatment last year.
Lilly’s shares fell 3.4 percent, while those of Incyte were down 5 percent in premarket trading.
New data provided by the companies in a resubmission of the marketing application did not substantially alter the information from the original submission, the staffers added here.
The FDA last April declined to approve the drug, baricitinib, in a move that came as a surprise to many and a blow to the companies, which were counting on a potential blockbuster.
Safety data supported a lower 2 mg dose of the drug but not a 4 mg dose, raising questions whether the higher dose provides additional benefit, the staffers said.
Moreover, the limited data available on the lower dose complicates the assessment of its risk/benefit analysis, the staffers said.
The review also brought up a serious safety risk of thrombosis that has not been observed in other therapies, especially Pfizer Inc’s Xeljanz, the agency said.
An independent panel of experts will hold an advisory meeting on Monday to assess the drug based on data from the companies and the analysis by FDA staff.
Reporting by Tamara Mathias in Bengaluru; Editing by Anil D’Silva and Sriraj Kalluvila