Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate
Interpret Survival Analysis “Cautiously,” Label Advises
The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.
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Public Company Edition: Prime Medicine raised $175m, making its offering the sixth-largest out of 19 biopharma IPOs in the US this year. Also, Oculis and AUM opted to go public via SPAC mergers, Insmed raised $775m from multiple financings and Dice capitalized on positive data with a $300m offering.
Regulatory Flexibility: US FDA Approves Amylyx’s Relyvrio For ALS Despite ‘Degree Of Residual Uncertainty’
The single positive Phase II CENTAUR study, along with confirmatory evidence of benefit on long-term survival in the open-label extension, demonstrate substantial evidence of effectiveness, the agency says, acknowledging a level of uncertainty that is acceptable in the disease context.
After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?