Novartis/Idenix HCV Studies Altered For GI Safety; Five Gleevec sNDAs Pending
This article was originally published in Pharmaceutical Approvals Monthly
Idenix’ revision to the dosing scheme across its Phase IIb clinical program for valopicitabine reflects the firm’s and FDA’s concern that serious gastrointestinal side effects could represent key dose-limiting adverse events for the hepatitis C agent.
You may also be interested in...
Revised labeling for Novartis'Gleevec (imatinib) advises that patients taking the medication who have cardiac disease or are at risk for cardiac failure should be closely monitored
Idenix hopes to finalize a Phase III trial protocol for its hepatitis C agent valopicitabine by March 2006, the firm says Dec. 2. FDA requested additional data from a Phase IIb trial during a Nov. 30 end-of-Phase II meeting; Idenix plans to submit the data in January. "Valopicitabine is an orally bioavailable pro-drug of a novel ribonucleoside analog, and is an inhibitor of HCV and related viruses," Idenix says. The company has other antivirals in development, including valtorcitabine and telbivudine, both for hepatitis B. A telbivudine NDA is slated for submission before year-end...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011