FDA may seek more safety data for RA therapies

FDA may require a "premarket safety database of larger size and longer duration" than currently recommended by the International Conference on Harmonisation (ICH) for NMEs to treat chronic rheumatoid arthritis. In new draft guidance on the clinical development of RA products, FDA noted that many can cause serious dose-related adverse reactions, including those with "longer latency periods" like opportunistic infections and malignancy that may not be apparent in short-term trials. The draft, which will replace guidance last published in 1999, also notes that sponsors should start dose-ranging studies early in the development program for RA products and continue the studies "throughout definitive efficacy and safety study(ies)." The guidance also notes that dose-ranging studies should use endpoints sensitive to dose-response changes, such as DAS28. ...