FDA Loosens Up HCV Drug Development

FDA Loosens Up HCV Drug Development - HCV Boston Meeting June 27, 2009



4th International Workshop on Hepatitis C
Resistance and New Compounds 25-26 June 2009, Boston, MA USA

Reported by Jules Levin

At the HCV meeting in Boston, Kim Struble from the FDA delivered a talk on expectations regarding HCV clinical drug development but the big news was that she announced the FDA loosened up a requirement for new HCV compounds regarding pre-clinical animal studies. Previously the FDA required before conducting a study of a combination of 2 oral HCV drugs in patients a company would be required to conduct an animal study giving the animal both of the 2 oral drugs in combination for 3 months. That has been loosened up so now a company only has to conduct a 3 month study giving an animal 1 oral for 3 months and an animal the 2nd oral for 3 months, in other words you don't have to give an animal both orals in combination together for 3 months, you only have to do 3 months of monotherapy for each oral drug independently. The Roche INFORM Study was conducted overseas because of that prior FDA requirement and researchers felt constricted by this rule, so now this loosening of that requirement should help to facilitate drug development. Also the Dr Struble encouraged companies to contact the FDA to inquire about questions they may have drug development rather than presuming they know the requirements, it seems often a company will assume they understand what is expected of them, but they are sometimes wrong. In a question from the audience about EPO Dr Struble appeared to me to leave the door open to EPO use. Another question from the audience asked about biopsy vs non-invasive testing and Dr struble said non-invasive tests are not yet validated so biopsy is required.