Pink Sheet Podcast: Accelerated Approval Reform, US FDA Patient Engagement, Drug Access and COVID-19
Pink Sheet reporter and editors discuss new accelerated approval legislation, the changing FDA patient-focused drug development initiative, and the importance of access for COVID-19 treatments.
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AstraZeneca/Sanofi’s Nirsevimab Nears US FDA Approval After Overwhelmingly Positive Adcomm
When patients should receive the RSV prevention treatment was the subject of much debate even as the Antimicrobial Drugs Advisory Committee voted nearly unanimously that it should be approved for infants and neonates.
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.