Are Accelerated Approvals the New Rage? Diving into Recent Accelerated Approvals - Including Aduhelm - BioNJ

Feb 23 2022

8:30 AM - 10:30 AM

Linda Pissott Reig, shareholder and co-chair of the firm's FDA practice, served as moderator for a BioNJ panel "Are Accelerated Approvals the New Rage? Diving into Recent Accelerated Approvals - Including Aduhelm."

Topics covered included:

Why Accelerated Approval exists and how its application is expanding
Challenges associated with identifying intermediate endpoints, particularly in non-cancer conditions (where endpoints viewed as predictive of clinical benefit, such as tumor shrinkage, may not be well defined)
How the benefit/risk calculus occurs despite incomplete evidence of clinical effect, particularly in conditions where the cause/pathogenesis of disease is not well understood
The important role of Patient advocacy groups in influencing policies even when FDA advisory committee support is absent