Truvada Pre-exposure Prophylaxis Claim Must Overcome Conflicting Subgroup Data
This article was originally published in The Pink Sheet Daily
FDA’s Antiviral Drugs Advisory Committee will have to wrestle with the same types of questions about efficacy across various populations and implications for real world use that were raised by the AIDS Healthcare Foundation in a recent citizen petition opposing approval of Gilead’s sNDA for the new indication.
You may also be interested in...
Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.
Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.