Defining 'Substantial Efficacy': Post Hoc Analysis OK (When FDA Does It)
Agency's interpretation of four unsuccessful trials of Fabre-Kramer's antidepressant seems like 'cherry picking' and could create an uneven playing field for sponsors, some advisory committee members say; nevertheless, panel overwhelmingly concludes efficacy was lacking.
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Do Negative Trials Count More Than Successful Ones?
Fabre-Kramer, FDA dispute over efficacy of the antidepressant gepirone heads to Psychopharmacologic Drugs Advisory Committee.
Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members
Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.
Eisai/Biogen’s Leqembi Sees Clear Path To Regular Approval For Alzheimer’s Disease
US FDA will ask its advisory committee to weigh anti-amyloid drug’s benefit-risk in populations at higher risk for adverse events, but agency says lecanemab’s risks ‘do not appear to preclude traditional approval’ and the CLARITY AD trial demonstrated clinical efficacy and a reduction in brain amyloid.