Complete response to hold on anemia drugs

The US Food and Durg Administration has accepted as complete the response to its clinical hold on two oral anemia drugs co-developed by USA-based FibroGen and Japanese drug major Astellas. Clinical studies of the hypoxia-inducible factor prolyl hydroxylase inhibitors, FG-2216 and FG-4592, were put on hold last year after a death due to fulminant hepatitis was reported in a Phase II US trial of the former in predialysis chronic kidney disease patients (Marketletter May 21, 2007).

Astellas in-licensed the compounds from US drugmaker FibroGen for exclusive development and marketing in Japan and Europe (Marketletter May 8, 2006). Under the terms of their agreement, the Tokyo-based company will pay a licensing fee of $300.0 million upon signing, milestones totaling $465.0 million and share in the costs of a transAtlantic development program and patent support.