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.
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The European Medicines Agency is meeting this week to decide whether two new drugs, including one that enhances anti-parkinsonian activity, should be approved for use in the EU. Also, the sponsor of a treatment for the rare degenerative muscle disorder, Pompe disease, is expected to attend an oral explanation meeting to address last-minute questions.
From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.
Biogen’s Aducanumab: One Positive Phase III Trial Is Good Enough For Demonstrating Efficacy, US FDA Says
Negative results from the Phase III ENGAGE trial – which may have been influenced by imbalance in ‘rapid progressors’ and differential effects of dosing protocol changes – do not negate persuasiveness of positive results from the EMERGE study, agency says in advisory committee briefing document; statistical reviewers dissent, call for a new trial of the Alzheimer's drug.