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Biogen files for FDA license for aducanumab

Wednesday 08 July 2020

On 8 July, the biotechnology company Biogen completed the submission of a biologics license application to the US Food and Drug Administration (FDA) for aducanumab as a treatment for Alzheimer’s disease (AD). The data underpinning the filing came from the phase III EMERGE and ENGAGE studies, as well as the Phase Ib PRIME study.

In October 2019, the company announced that the Phase III EMERGE trial met its primary endpoint, showing a significant reduction in clinical decline. The investigational drug was tested in people with mild cognitive impairment due to AD and mild AD dementia. However, the Phase III ENGAGE study did not meet its primary endpoint with the same participant group.

The aducanumab clinical programme also included the results of the Phase Ib PRIME study and its long-term extension in people with early AD. Findings showed that aducanumab reduced amyloid beta plaques in a dose- and time-dependent manner and reduced clinical decline.

Biogen requested a priority, six-month review. The company is continuing to engage dialogue with regulatory authorities in Europe and Japan.

https://investors.biogen.com/news-releases/news-release-details/biogen-completes-submission-biologics-license-application-fda

UPDATE: The FDA has granted Biogen's application priority review, meaning the response will come by 7 March 2021. Read more, here.

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