Amgen submits new Anakinra data to US FDA

Amgen has submitted new data to the US Food and Drug Administration fromtwo large-scale clinical trials which support the previously-reported efficacy and safety of anakinra, said to be the first specific interleukin-1 inhibitor under development for the treatment of rheumatoid arthritis. An efficacy study included 500 rheumatoid arthritis patients while a safety trial comprised over 1,300 patients, all of whom were "selected to reflect the range of patients seen in actual clinical practice," according to Alan Solinger, Amgen's lead rheumatologist. The results are consistent with those already submitted in the Biologics Licence Application for anakinra, said the company.