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FDA sets November date for expert panel review of Biogen’s aducanumab

Advisory committee will review biologics license application for controversial therapy

The US Food and Drug Administration (FDA) panel is set to review Biogen’s controversial Alzheimer’s disease treatment aducanumab on 6 November.

The meeting of the Peripheral and Central Nervous System Drugs Advisory Committee is set to provide advice and recommendations based on the biologics license application submitted by Biogen for aducanumab.

In August, Biogen picked up a fast-track review from the FDA for the potential Alzheimer’s treatment, a notable milestone for the company after a particularly rocky road to regulatory submission.

Last October, Biogen announced its intention to file aducanumab for approval only a few months after abandoning the drug in phase 3.

The experimental Alzheimer’s therapy was initially scrapped after an independent data monitoring committee recommended halting the trials after determining the drug couldn’t slow the rate of disease progression in participants.

However, Biogen surprised investors when it announced that a closer analysis of a subset of patients in the phase 3 EMERGE study warranted taking aducanumab to global regulators.

In this dataset, patients who received sufficient exposure to high doses of the drug experienced benefits on measures of cognition and function, including memory, orientation and language.

Biogen maintained that the failure of aducanumab in a second trial – ENGAGE – was most likely due to the fact that there weren’t a sufficient number of patients receiving enough exposure to the higher dose of the medication.

Experts have responded to the mixed results with scepticism, although considering the lack of promising treatments for Alzheimer’s coming through the pipeline, the data could be enough for aducanumab to score approval.

According to GlobalData analyst Alessio Brunello, the FDA is 'unlikely to turn down aducanumab even if its benefit is modest, given the lack of any therapy that is truly efficacious'.

If it does win approval, aducanumab could be on track to hit almost $4.7bn in sales across the seven largest pharma markets worldwide in 2026, as forecast by GlobalData.

The FDA has set a prescription drug user fee act (PDUFA) action date for aducanumab of 7 March 2021, although the agency stated that, if possible, it will act early on this application under an expedited review.

This looks increasingly likely, although it will entirely depend on the outcome of the upcoming advisory committee.

Article by
Lucy Parsons

29th September 2020

From: Regulatory



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