Mitsubishi Tanabe Pharma Corporation
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Latest From Mitsubishi Tanabe Pharma Corporation
Amylyx Relyvrio: Pricing, Compounding, And The Shadow Of Makena
The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.
Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate
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.
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.
How Will Approval Of Amylyx’s Relyvrio Impact The Ongoing PHOENIX Trial?
Launched in part to help resurrect AMX0035’s regulatory prospects, the multiregional PHOENIX study is winding down in the US. There still may be some risk of potential dropouts, however.
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- BIXEN Corporation
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- NeuroDerm, Ltd. (NDRM)
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- Tai Tien Pharmaceuticals Co., Ltd.
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