FDA guides development of finite therapies to cure HBV

FDA guides development of finite therapies to cure HBV

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BioCentury
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FDA released draft guidance Thursday to encourage development of finite, curative HBV treatments that have a low risk of virologic relapse and minimal risk of liver disease progression after treatment. FDA recommended developers use a two-pronged primary efficacy endpoint of sustained HBV DNA suppression off-treatment and HBV surface antigen (HBsAg) loss.