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Amylyx Pharmaceuticals, Inc.

http://amylyx.com

Latest From Amylyx Pharmaceuticals, Inc.

BrainStorm Hoping For Advisory Committee After FDA Refuses To File BLA For Its ALS Cell Therapy

BrainStorm, which has a history of antagonizing FDA with direct appeals to patients for NurOwn, tells investors that public elements of an adcomm could be ‘persuasive,’ but first step will be formal meeting request to try to overcome the RTF. Firm sees Relyvrio as template for success.

Neurology Drug Approval Standards

Amylyx’s Relyvrio: US FDA Review Shows Regulatory Flexibility Can Come In Many Forms

Pink Sheet Drug Review Profile looks at how the agency determined that Amylyx’s ‘conceptual basis’ for use of the drug’s two active ingredients to treat ALS was enough to satisfy the combination drug rule; the sponsor also was allowed to submit certain animal studies and drug-drug interaction data during the course of the NDA review.

Drug Review Profile Approvals

Early PHOENIX Data Would Not Have Aided Approval Decision On Amylyx’s Relyvrio – US FDA

Agency considered Amylyx’s plan to submit unblinded efficacy data from the ongoing Phase III trial during the ALS drug's NDA review but ultimately decided against it, citing concerns about study integrity and the small amount of data likely to be available.

Drug Review Profile Drug Review

Real-World Evidence: Amylyx’s Use Of External Controls To Frame Relyvrio’s Survival Benefit Rife With Problems

The post hoc comparison of an exploratory, long-term survival benefit in the CENTAUR trial to historical controls in two ALS patient databases lacked prespecification and a common treatment protocol, and potential differences in prognostic factors may have confounded the results.

Drug Review Profile Drug Review
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