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.
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In an interview with the Pink Sheet, Stealth’s CEO says she is not confident the company could design a clinical trial in the rare disease that would meet the FDA’s expectations.
US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says
In a letter to Commissioner Robert Califf, the Patient, Consumer and Public Health Coalition says medical product center directors and other senior staff should refrain from trying to sway advisory committee votes and be reminded that overruling decisions of their own scientific staff undermines the public trust.
MSD/Ridgeback Biotherapeutics’ COVID-19 treatment Lagevrio is among the products that are up for an opinion this week from the European Medicines Agency on whether they should be recommended for use across the EU.