GlaxoSmithKline said the PDUFA goal date for albiglutide, its investigational once-weekly GLP-1 treatment for adult patients with type 2 diabetes, has been extended by three months to April 15, 2014, “to provide time for a full review of information submitted by GSK in response to the [FDA’s] requests.” GSK filled a BLA to the FDA for albiglutide in January, followed by a submission to the EMA in March. GSK said the EMA filing is “progressing to schedule.” The drug would compete with BMS/AZ’s Bydureon, also a once-weekly shot.
A professional sales aid from Spectrum Pharmaceuticals‘ cancer infusion Zevalin minimized risk information, overstates efficacy and omits material facts, said OPDP in an untitled letter dated July 23 and recently posted on the FDA website. OPDP said the conduct occurred despite repeated advisory comments addressing similar misleading presentations on five other occasions.
