Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your experience. Save up to 40% More details

FDA decision on Eisai, Biogen Alzheimer's drug due in January

Sports & General Jul 06, 2022 02:42AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

By Deena Beasley

(Reuters) -The U.S. Food and Drug Administration will expedite its review of Eisai Co (OTC:ESALY) Ltd's and Biogen Inc (NASDAQ:BIIB)'s experimental Alzheimer's drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.

Lecanemab, like the partners' previous drug Aduhelm, is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s, a disease that leads to memory loss and the inability to care for oneself.

The FDA controversially approved Aduhelm in June last year, although only one of two late-stage trials showed it helped slow cognitive decline. The FDA's own panel of outside experts had advised against approval.

Biogen subsequently slashed its price for the drug to $28,000 per year from an initial $56,000. But Medicare, the U.S. government health plan for people over age 65, this year said it would only pay for Aduhelm if patients were enrolled in a valid clinical trial, serving to sharply curtail the medication's use.

Eisai in March downsized its role in Aduhelm, but remains the leader in the 50-50 partnership's lecanemab program.

Shares of the Japanese company jumped on the news, gaining more than 4% in Tokyo trade and making Eisai the second-biggest gainer on the benchmark Nikkei 225.

Under the FDA's accelerated pathway, lecanemab needs to show it can effectively interfere with underlying changes that lead to Alzheimer’s dementia, rather than prove any impact on cognition. Such a "biomarker" would be the level of amyloid proteins in the brain.

That is the same standard the FDA used for approving Aduhelm - leaving many critics unconvinced of the drug's efficacy.

Eisai said it would have results from a large, Phase 3 trial of lecanemab available this fall, which will answer the question of whether the drug has an impact on cognitive ability.

The 1,800-patient study is designed to show that the drug can slow the rate of cognitive and functional decline by at least 25%.

"Here in the U.S. we obviously will do our very best to make lecanemab available within the allowable coverage by different payers," Ivan Cheung, Eisai's U.S. chairman, told Reuters.

He said initial "top-line" results from the trial are expected by late September.

Eisai said the FDA has agreed that results from that trial can serve as a confirmatory study to verify the clinical benefit of lecanemab. Depending on those results, Eisai said it could seek full FDA approval of the drug before the end of its current fiscal year on March 31, 2023.

The company said it initiated in March an application with Japan's Pharmaceuticals and Medical Devices Agency, and aims to file for approval of lecanemab during that same time period based on the Phase 3 trial results.

Pending the trial findings, Eisai said it also plans to submit a new drug application in Europe.

FDA decision on Eisai, Biogen Alzheimer's drug due in January

Related Articles

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at’s discretion.

Write your thoughts here
Are you sure you want to delete this chart?
Post also to:
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Are you sure you want to delete this chart?
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Continue with Google
Sign up with Email