Get 40% Off
🤯 This Tech Portfolio is up 29% YTD! Join Now to Get April’s Top PicksGet The Picks – Just 99 USD

FDA grants expedited review to Biogen's Alzheimer's drug

Published 2020-08-07, 10:32 a/m
Updated 2020-08-07, 10:36 a/m
© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge

© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge

(Reuters) - Biogen Inc (NASDAQ:BIIB) and Japan's Eisai Co Ltd said on Friday the U.S. Food and Drug Administration has granted an expedited review for the marketing application of their potential blockbuster Alzheimer's drug aducanumab.

Biogen's shares were up 10% at $306 before the bell.

If approved, aducanumab would be the first treatment designed to delay progression of the fatal, mind-robbing disease, which is expected to affect 13.9 million Americans or 3.3% of the country's population by 2060, according to the U.S. Centers for Disease Control and Prevention.

It has been several years since the FDA reviewed an application for a new Alzheimer's treatment, as drugs that were tested failed trials. The agency is expected to take a decision by March 7, but intends to act early on it if possible, the companies said.

Biogen in October revived plans to seek approval for the treatment, months after scrapping the development of the drug following disappointing study results.

Wall Street analysts have been divided about the data from the clinical studies.

"There still are a ton of questions surrounding the aducanumab dataset," Stifel analyst Paul Matteis said.

The drug regulator would consult a panel of outside experts on a yet-to-be-determined date for the approval of the drug, the companies said. The agency is not required to follow the panel's recommendation, but often does.

"We largely view an advisory committee as one of the big 'clearing events' and predict it will be 'mixed,' leaving the Street in limbo," Jefferies analyst Michael Yee said.

The FDA has granted a priority review, which allows it to accelerate the review of an application for drugs aimed to treat an unmet medical need.

© Reuters. FILE PHOTO: A sign marks a Biogen facility in Cambridge

Biogen said it did not use its priority review voucher for the aducanumab application.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.