FDA: Abbott’s Psoriasis Treatment May Need More Analyses, Trials

Abbott Laboratories has withdrawn its BLA and EU marketing authorization application for its psoriasis treatment briakinumab after regulatory authorities indicated more trials may be necessary. Abbott plans to evaluate next steps for the drug, including resubmission, it said. The preliminary feedback from the agencies pointed to the need for further analyses and the potential for additional studies that could not be generated during the review time frame, Abbott spokeswoman Kelly Morrison said. The withdrawal is a surprise given that the company released strong Phase III briakinumab results in October.
Clinical Trials Advisor