Sponsors Caution Against Premature Expanded Access For Novel HCV Drugs
This article was originally published in Pharmaceutical Approvals Monthly
Early positive trial results for direct-acting antivirals for Hepatitis C, combined with the seriousness of the disease and unmet clinical need, make Hep C an obvious target for expanded access programs.
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FDA is developing guidances -both in general and for specific therapeutic areas - for co-development of investigational drugs intended to be used in combination, and the move is indeed timely.
Providing an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say