Aduhelm's Journey To Accelerated Approval: Finding Buried Treasure In Uncharted Waters
The Alzheimer’s drug’s regulatory voyage to accelerated approval was circuitous – a destination briefly visited but one that reappeared on the horizon only as time ticked down on the application’s user fee goal date.
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In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.
But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.
FibroGen’s Roxadustat Faces US FDA Scrutiny On ‘Prominent’ Safety Signals Relative To Erythropoietin
Risks of serious thrombotic events, seizures and infection make the benefits of the first-in-class oral drug for treating anemia related to chronic kidney disease ‘difficult to calculate’ despite demonstrated improvements in hemoglobin, FDA says in advisory committee briefing document.