US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.
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Will US FDA Advisory Committees Rebound In 2023?
The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?
The Return Of The Advisory Committee: US FDA Has Busy Fall Ahead
The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.
ALS Drugs: Second US FDA Meeting On AMX0035 Gives Amylyx A Chance To Capitalize On Recent Events
Company is coming into its second panel meeting with new data analyses from the CENTAUR trial, advisory committee experience under its belt, and a recent Health Canada approval. In an interview with the Pink Sheet, co-CEOs Cohen and Klee highlight clinical outcomes data with AMX0035 and say they are not too worried about the lack of effect on neurofilament biomarker.