Amylyx ALS Drug: ICER Revised Evidence Report Casts Doubt On Firm’s New Data Analyses
ICER’s take on the Amylyx analyses raises questions about whether FDA will take a similar view and suggests payers may restrict coverage upon approval, at least initially, should it carry a very high price tag.
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The US drug pricing watch dog issued a final assessment on Amylyx's AMX0035 and Mitsubishi Tanabe's Radicava for ALS.
ALS Drugs: FDA Panel Weighed Less-Than-Ideal Data Against Amylyx’s Ability To Set Postapproval Price
National Institute on Aging’s Brian Traynor questioned whether Amylyx would seek to recoup its money on AMX0035 in 2-3 years, before the Phase III PHOENIX trial completes, or whether pricing would be based on long-term market expectations. NINDS’ Kenneth Fischbeck said Amylyx should reopen US sites in Phase III trial and broaden expanded access instead of seeking approval now.
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.