Biogen shares drop as big clinics say they won’t administer controversial Alzheimer’s drug

CNBC Television published this video item, entitled “Biogen shares drop as big clinics say they won’t administer controversial Alzheimer’s drug” – below is their description.

Cleveland Clinic and Mt. Sinai won’t administer Aduhelm, a controversial but recently FDA-approved Alzheimer’s drug. Both clinics issued statements which said they have problems with the FDA approval process for the drug. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi

Acting Food and Drug Administration Commissioner Dr. Janet Woodcock on Wednesday pushed back against questions from a journalist about the controversial approval of Biogen’s Alzheimer’s medication, Aduhelm.

During an interview at STAT’s Breakthrough Science Summit, STAT reporter Nicholas Florko asked Woodcock several questions about the drug, including whether she was surprised it was approved by the agency for such broad use.

When the FDA approved Aduhelm last month, it did not restrict its use to specific Alzheimer’s patients. But after facing intense criticism, U.S. regulators changed course about a month later, updating the label and narrowing the drug’s use for people with mild or early-stage Alzheimer’s.

Woodcock said Wednesday that the broader label was consistent with other drugs for neurodegenerative diseases. The FDA chief also acknowledged that the approval process of Biogen’s drug could have potentially been handled differently.

“It’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved,” she said.

Florko asked whether she was surprised about the label. She replied: “I think we ought to move on.”

When Florko then pressed Woodcock if she was aware of a reported meeting between an FDA regulator and Biogen in 2019, Woodcock said she was working all last year for Operation Warp Speed, former President Donald Trump’s Covid drug and vaccine program. She then said, “Nick, this is an interrogation right now,” and asked again that they move on from questions about the biotech company’s drug.

“I’m not going to comment on if and when and who. I really think we ought to move on,” she replied.

The interview came less than a week after Woodcock called for a federal investigation into the approval of Biogen’s drug. On Friday, she asked the independent Office of Inspector General to investigate interactions between the U.S. agency and Biogen prior to the drug’s approval on June 7.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. The drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

The investigation is the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

» Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision

» Subscribe to CNBC: https://cnb.cx/SubscribeCNBC

» Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic

Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide.

The News with Shepard Smith is CNBC’s daily news podcast providing deep, non-partisan coverage and perspective on the day’s most important stories. Available to listen by 8:30pm ET / 5:30pm PT daily beginning September 30: https://www.cnbc.com/2020/09/29/the-news-with-shepard-smith-podcast.html?__source=youtube%7Cshepsmith%7Cpodcast

Connect with CNBC News Online

Get the latest news: http://www.cnbc.com/

Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC

Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC

Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC

Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBC

https://www.cnbc.com/select/best-credit-cards/

#CNBC

#CNBCTV

CNBC Television YouTube Channel

Got a comment? Leave your thoughts in the comments section, below. Please note comments are moderated before publication.

About This Source - CNBC Television

CNBC is an American pay television business news channel, which primarily carries business day coverage of U.S. and international financial markets. Following the end of the business day and on non-trading days, CNBC primarily carries financial and business-themed documentaries and reality shows.

As of February 2015, CNBC is available to approximately 93,623,000 pay television households (80.4% of households with television) in the United States.

Recent from CNBC Television:

  • House may limit what goes into an IRA
  • Saxo Bank’s Ole Hansen on what’s behind the natural gas price surge
  • LIVE: SpaceX to launch four civilians to orbit in mission known as Inspiration4 ⁠— 9/15/21
  • In This Story: COVID-19

    Covid-19 is the official WHO name given to the novel coronavirus which broke out in late 2019 and began to spread in the early months of 2020.

    Symptoms of coronavirus

    The main symptoms of coronavirus are:

    • a persistent new cough (non productive, dry)
    • a high temperature (e.g. head feels warm to the touch)
    • shortness of breath (if this is abnormal for the individual, or increased)

    Latest News about Covid-19

    Below are stories from around the globe related to the 2020 outbreak of novel Coronavirus – since the WHO gave the Covid-19 naming. Most recent items are posted nearest the top.

    5 Recent Items: COVID-19

  • Coronavirus pandemic: Iran accelerates vaccine campaign • FRANCE 24 English
  • Germany’s COVID vaccination rate stagnates at 62% | DW News
  • Why unemployment is down but none of your friends are at work | The Business | ABC News
  • UK Covid-19: Labour accuses Boris Johnson’s Govt of being ‘tone-deaf’ on face mask messaging
  • Concerns over COVID-19 positive truck driver in Queensland | Coronavirus | 9 News Australia
  • Leave a Comment

    We don't require your email address now, just your name. BUT, if you do add it, you may be notified if there are replies to your comment. Please make respectful comments, which add value, and avoid personal attacks on others. Comments failing to adhere to these guidelines will not be published.