Hints of a higher bar in HBV
Adefovir dipivoxil from Gilead Sciences Inc. sailed through last week's Antiviral Drugs Advisory Committee meeting, with the panel unanimously recommending approval to treat chronic hepatitis B (CHB) in adults with active liver disease based on histological data. At the same time, the committee voiced concerns about using adefovir in patients with renal impairment and in patients co-infected with HIV. And importantly for other companies developing HBV treatments, FDA's analysis of the data imply that the agency might yet again raise the bar for approving new HBV drugs.
A new standard
The advisory panel spent little time worrying over the primary data. To a person, the committee expressed no hesitation in signing off on the use of Adefovir to treat CHB patients