US FDA's New Neurology Leadership Likely To Face Two Big Reviews In 2020
Eric Bastings will lead Division of Neurology I, which is expected to handle Biogen’s Alzheimer’s drug aducanumab and Sarepta’s refiling of golodirsen for DMD next year.
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A Tale Of Two DMD Drugs: Theme And Variation In Controversial US FDA Reviews
Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.