Breaking News
0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

Analysis: Rival treatments may help justify FDA gamble with Biogen Alzheimer's drug

Stock MarketsJun 18, 2021 07:26AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 
2/2 © Reuters. FILE PHOTO: Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake/File Photo 2/2

By Deena Beasley and Julie Steenhuysen

(Reuters) - Data from clinical trials of three experimental Alzheimer's disease drugs expected to start emerging next year could help shed light on whether U.S. regulators were justified in their controversial approval of a Biogen Inc (NASDAQ:BIIB) treatment without clear evidence that it works.

In approving Biogen's Aduhelm over the objection of its own panel of outside expert advisers, the U.S. Food and Drug Administration has required a trial to confirm that the medicine will indeed slow progression of the lethal, mind-wasting disease - a process that could take several years - even as the drug is being used by patients.

But data expected much sooner on three drugs that work in a similar manner - Eli Lilly (NYSE:LLY) and Co's donanemab, Roche Holding AG (OTC:RHHVF)'s gantenerumab, and partners Eisai Co (OTC:ESALY) and Biogen's lecanemab - could give the medical community a better sense of whether Aduhelm is up to the job of slowing the ravages of Alzheimer's.

Aduhelm was approved last week based on its ability to clear a type of plaque from the brain that is believed to be a possible cause of Alzheimer's, rather than evidence that it slows disease progression. The FDA contends the plaque removal is likely to benefit patients, an assertion many experts say is unproven.

"I don't feel that we have evidence now that there's a clinical benefit from reducing amyloid," said Dr. Henry Paulson, a neurologist who leads the University of Michigan's Alzheimer’s Disease Center.

"If another independent study of a different anti-amyloid therapy shows a clear clinical benefit, it makes me much more comfortable with continued use of Aduhelm," he said.

All four drugs are antibodies aimed at reducing the accumulation of the sticky plaques composed of a protein called beta amyloid found in the brains of people with Alzheimer's, a disease that currently afflicts some six million Americans.

Positive data from the three experimental medicines could also provide an indication of future competition for Aduhelm, which was developed in partnership with Eisai and is currently the only drug that targets an underlying cause of the disease.

Large clinical trials of Aduhelm, known chemically as aducanumab, produced contradictory data, with one trial failing and another showing benefit. There was also a potentially serious brain swelling side effect.

Nevertheless, the FDA approved Aduhelm under its "accelerated approval" program with the understanding that Biogen would conduct a post-marking study to demonstrate patient benefit.

FDA officials said other Alzheimer's drugs will not automatically be eligible for that program. "We can't say right now whether this will be a path for other Alzheimer's drugs, or drugs for other neurodegenerative diseases," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, told Reuters.

'PRECEDENT-SETTING'

Critics say the decision does change the landscape for future drugs.

"This is precedent-setting whether the FDA likes it or not," said Dr. Caleb Alexander, a Johns Hopkins public health professor and one of the remaining members of the FDA advisory panel that reviewed Aduhelm. Three members of the panel resigned after the FDA approval.

"That's not to suggest that the next drug that lowers amyloid is a slam dunk or even gets approved. It may not," he said.

For the near future, Biogen will have the market to itself, but analysts are watching potential future rivals closely.

"If another drug comes along and maybe doesn't have as many side effects, or maybe has slightly better data, Biogen's position could be jeopardized," said Raymond James health policy analyst Chris Meekins.

Japan's Eisai completed enrollment last month in a pivotal 18-month study of lecanemab in symptomatic early Alzheimer's patients. The drug is also being studied in a large trial of people with evidence of amyloid in their brains who do not yet have symptoms of the disease.

Roche, which has released limited gantenerumab trial findings, said it expects to have data next year from two global late-stage studies of its drug.

Eli Lilly announced encouraging results in March from a mid-stage study of donanemab and plans to conduct a larger trial.

"I think it is quite likely that if they can replicate those results it would be approved," said Dr. David Knopman, a neurologist at the Mayo Clinic in Rochester, who quit FDA's advisory panel in protest over the Aduhelm approval.

Analysis: Rival treatments may help justify FDA gamble with Biogen Alzheimer's drug
 

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 Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
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?
 
Post
 
Replace the attached chart with a new chart ?
1000
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 Investing.com'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
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email