A timeline of Aduhelm’s rise and fall

The story of Aduhelm has been rocky now for years. Biogen turned heads when its controversial Alzheimer’s therapy won accelerated approval from the FDA against the advice of its own advisory panel in mid-2021. The company had high hopes for the antibody at that point, pricing it at an average of $56,000 per year. Aduhelm would encounter a series of blows after that – rejected coverage, dismal sales, discontinued trials. Biogen would ultimately pull the plug on the drug this year.

Now, Biogen aims to prioritize other Alzheimer’s programs like the lecanemab, which was jointly developed with Eisai and FDA-approved in July 2023. Biogen noted in a statement that insights gained from Aduhelm hold value for the company. Ultimately, Biogen recorded a $60 million charge tied to wrapping up Aduhelm’s development.

A timeline showing the ups and downs in Aduhelm’s journey in reverse-chronological order follows. Stock data are from Yfinance and annotation chart …

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How the CMS decision to limit Aduhelm coverage could impact Medicare pricing

Since winning approval for the Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq: BIIB) has faced a punishing string of setbacks. As a result, the company’s share price is currently trading near $200 per share — less than half of its $414.71 peak on June 10, 2021.

In April 2022, the Centers for Medicare & Medicaid Services (CMS) dealt one of the most punishing blows to Aduhelm’s future by limiting coverage for the drug to clinical trial participants.

The CMS decision was “certainly an unusual action from CMS,” said Corey Metzman, chief operating officer and co-founder of Chapter, a data-driven digital Medicare advisor. Typically, CMS grants Medicare coverage to FDA-approved drugs. “What was unique about [Aduhelm] is that it went through the accelerated approval process.”

Another wrinkle is that the drug failed to win the backing of the FDA’s Peripheral and Central Nervous System Drugs A…

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Nine out of ten U.S. neurologists have Aduhelm efficacy doubts

A recent physician survey found that 89% of neurologists in the U.S. have concerns about the efficacy of the controversial Alzheimer’s drug Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and Eisai Co. (TYO:4523). Nearly as many — 87% — were concerned about the drug’s safety profile.

The survey from the physician social media network Sermo (New York City) asked more than 50 neurologists about their view of the drug, which has failed to find widespread use, generating just $3 million in 2021. Only 11% of the neurologists surveyed reported prescribing the drug.

Despite low uptake, many patients are aware of the drug. A total of 62% of the surveyed neurologists reported that at least one patient had asked them about Aduhelm.

The drug has faced an array of challenges since it was FDA-approved in June 2021. Recently, Medicare decided to limit Aduhelm’s coverage of the drug to clinical trial participants, and other payers, including the Department of Veteran Af…

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Biogen CEO Michel Vounatsos to step aside as Aduhelm sales continue to sputter

With the blockbuster dreams of the Alzheimer’s drug Aduhelm (aducanumab) dashed for the foreseeable future, Biogen has announced that its CEO Michel Vounatsos will depart.

Vounatsos began his tenure as CEO in 2017.

Vounatsos’ plans to exit the company came out on the same day that Biogen reported Q1 adjusted earnings per share of $3.62, 76¢ behind the $4.38 that analysts expected. The 76¢ amount was equal to the negative impact that Biogen reported to Aduhelm inventory write-offs.

Revenue was $2.532 billion for the quarter ended March 31, 2022, down 6% from Q1 2021.

The company’s decision to pursue the FDA approval of Aduhelm after two Phase 3 trials failed to show a clear benefit proved controversial.

Michel Vounatsos [Image courtesy of Biogen]

Although the company would eventually win approval of Aduhelm in June 2021 under the accelerated approval program, the drug…
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Biogen gives up seeking European approval for aducanumab

After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks.

Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021.

At that time, Biogen announced that it would fight the decision.

In April, the company notified EMA that its decision to withdraw its application was “based on interactions with the CHMP [Committee for Medicinal Products for Human Use] indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm (aducanumab).”

“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” said Dr. Priya Singhal, head of global safety and regulatory sciences …

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Alzheimer’s group files FOIA request related to CMS decision on amyloid-targeting antibodies 

UsAgainstAlzheimer’s, a nonprofit organization committed to stopping Alzheimer’s disease, is hoping to get more information related to CMS’s national coverage determination related to coverage for Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and other monoclonal antibodies targeting amyloid to treat Alzheimer’s disease.

The organization has filed a Freedom of Information Act (FOIA) request for information about the decision.

UsAgainstAlzheimer’s is seeking information describing the potentially harmful impact of refusing to cover such monoclonal antibodies outside of clinical trials.

CMS announced their national coverage determination for Aduhelm and other similar future monoclonal antibodies last week.

UsAgainstAlzheimer’s concluded that CMS has denied access to millions of people in the U.S. living with Alzheimer’s.

“The National Coverage Determination is historic – and not in a good way. CMS has covered every FDA-approved drug, but now…

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Get the full story at our sister site, Pharmaceutical Processing World.

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CMS will limit coverage of Aduhelm to people in clinical trials

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab).

Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval and, about a week later, nonprofit watchdog group Public Citizen called for high-profile resignations for FDA officials as a result of the approval.

In August 2021, the HHS Office of Inspector General announced that it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug.

Yesterday’s CMS policy stated that Aduhelm and any future monoclonal antibodies directed against amyloid approved by the FDA will be covered by Medicare under coverage with evidence development (CED). CMS will, as part of the decision, provide enhanced acces…

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Eisai amends Aduhelm collaboration with Biogen

Aduhelm (aducanuamab) co-developer Eisai Co. (TYO:4523) has agreed to modify its economic partnership agreement with Biogen (Nasdaq:BIIB).

Starting January 1, 2023, Eisai will receive a tiered royalty on net sales of the Alzheimer’s disease therapy Aduhelm (aducanumab) rather than share profits or losses of the drug.

Eisai would receive between 2% and 8% of annual sales of the Aduhelm.

The Tokyo-based company also has given Biogen total decision-making power and commercialization rates globally for Aduhelm.

Analysts’ projections for Aduhelm have dimmed significantly in the wake of the drug’s approval by FDA in June 2021.

Eisai’s partnership with Biogen on the investigational Alzheimer’s drug lecanemab collaboration will remain unchanged globally. The two companies, however, have agreed to extend a supply agreement from five to 10 years that would have Biogen manufacture the drug candidate.

Lecanemab, lik…

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Biogen plays up spinal muscular atrophy pipeline

As Biogen Inc. (Nasdaq: BIIB) continues to struggle to capitalize on the Alzheimer’s drug Aduhelm (aducanumab), the company is highlighting new data from its Spinraza (nusinersen) and spinal muscular atrophy (SMA) research program.

First approved in 2016, Spinraza is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated to treat spinal muscular atrophy (SMA).

At the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference held March 13-16, 2022), Biogen will describe the Phase 3b ASCEND trial design. The company recently announced that it had enrolled the first patient in ASCEND and continues to enroll participants in that study.

Biogen is also sharing data from the Phase 4 RESPOND trial, which is testing the safety and efficacy of Spinraza in infants and toddlers with unmet clinical needs after receiving Zolgensma (onasemnogene abeparvovec).

The company also will provide an update from the Phase 2 NURTURE …

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Biogen to sell equity stake in Samsung Bioepis joint venture for up to $2.3B

After moving to accelerate a confirmatory clinical trial of the Alzheimer’s drug Aduhelm, Biogen (NSDQ:BIIB) plans on selling its equity stake in the Samsung Bioepis joint venture for up to $2.3 billion.

The deal would give Biogen $1 billion in cash and $1.25 billion to be paid in two installments after that. In addition, Biogen could receive an additional $50 million if agreed-upon commercial milestones are met.

Samsung Bioepis has one of the largest portfolios of biosimilars in the industry.

Samsung Biologics and Biogen announced the joint venture in 2012.

Under the terms of the agreement, Biogen will retain rights to BYOOVIZTM (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab) and the investigational biosimilar candidate SB15 (aflibercept), a proposed biosimilar referencing EYLEA.

BIIB shares increased 2.31% to $224.00 in after-hours trading.

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Patient groups voice disapproval for CMS proposal to limit coverage of aducanumab 

Image by Gerd Altmann from Pixabay

Biogen’s (NSDQ:BIIB) Alzheimer’s drug Aduhelm (aducanumab) continues to be a source of contention. Advocates cite the need for a new therapy for the memory-robbing disease while skeptics remain unconvinced about the benefit-risk profile of the drug. 

Most recently, Alzheimer’s disease advocates have criticized Medicare’s proposal to constrain coverage for the drug to clinical trial participants. 

The patient groups the Alzheimer’s Association, UsAgainstAlzheimer’s and the Global Alzheimer’s Platform Foundation have vowed to help overturn that decision by reaching out to the U.S. Health Secretary, lawmakers and officials within the Biden administration. 

The proposal would also apply to similar monoclonal antibodies that target the peptide amyloid-β (Aβ) and the protein tau to target Alzheimer’s.  

The Centers for Medicare & Medicaid Services (CMS) p…

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