Aducanumab Archives - Medical Design Sourcing

Biogen halts observational post-marketing study of aducanumab

Biogen (Nasdaq:BIIB) has terminated a study of the controversial Alzheimer’s disease drug Aduhelm (aducanumab) as a result of limited national policy for coverage.

In a listing on clinicaltrials.gov, the company notes that it anticipates there will limited prescriptions of the drug in routine clinical practice, which would provide limited enrollment for the planned ICARE AD study.

The study would have been a prospective, single-arm, multicenter study of aducanumab with up to 5 years of follow-up. The study would have collected data via routine visits every 6 to 12 months, but after opening up recruitment in November, only 29 volunteers had enrolled, according to data posted on clinicaltrials.gov.

Biogen and its partner Eisai (TYO:4523) announced their plans to launch the observational study in a presentation at the July 2021 Alzheimer’s Association International Conference. The drug had won FDA approval a month earlier.

Biogen still has a Phase 4 …

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…

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…

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 …

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…

Biogen unveils FTC aducanumab probe

In its annual SEC report, Biogen reported that the Federal Trade Commission had sent the company a civil investigative demand related to the controversial Alzheimer’s drug aducanumab (Aduhelm).

The company received a similar notice from the SEC.

Lawmakers in the U.S. House of Representatives and the Office of Inspector General of HHS are also investigating the approval and marketing of the drug.

The House Committee on Oversight and Reform had balked at Biogen’s initial plan to price the drug at $56,000 for a patient with an average weight. However, the company later cut the cost by approximately half.

Aducanumab exemplifies one of the most troubled drug rollouts in recent memory.

CMS has proposed drastically limiting coverage of aducanumab and other future drugs until more convincing efficacy data are available.

Aduhelm generated approximately $3 million in revenue in 2021.

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…

Medicare recommends covering aducanumab for clinical trial volunteers only

Demand for Biogen’s (NSDQ:BIIB) monoclonal antibody Aduhelm (aducanumab) has been weak, leading the company to cut the wholesale cost of the drug in half to $28,200 for patients with an average weight.

Now, Medicare officials reached a preliminary conclusion that federal coverage of the drug should be limited to clinical trial participants.

The agency went further, stating that coverage of the broader class of monoclonal antibodies targeting amyloid for Alzheimer’s would be limited to CMS-approved randomized controlled trials and trials supported by the NIH.

“This proposed decision will enable researchers to collect crucial data to evaluate the clinical benefits of these drugs,” wrote Dr. Richard J. Hodes, director, National Institute on Aging at NIH, in a statement.

Last week, Bloomberg published an op-ed recommending that Medicare coverage of Aduhelm be constrained to clinical trial participants.

In after-hours trading, BIIB shares fell 6…

Japan appears to eye Alzheimer’s drug Aduhelm with skepticism

Japan could follow the lead of the European Medicines Agency, which recommended refusing the marketing authorization of the controversial drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (Tokyo).

Japan’s First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council recommended further discussion of the application for the drug. The NDC also requested additional information as it continues its decision-making process.

The Japanese regulators voiced skepticism about clinical data correlating reductions in beta-amyloid with improvement in Alzheimer’s symptoms.

Biogen said it would continue collaborating with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the matter.

Biogen plans on beginning a confirmatory trial for Aduhelm next year, which could conclude in 2026.

Owing to weak demand for the drug in the U.S., Biogen announced that it was slashing the wholesale cost of the drug in hal…

Biogen’s eyeing layoffs as Aduhelm sales sputter: Report

As Biogen (NSDQ:BIIB) continues to struggle to market the controversial drug Aduhelm (aducanumab), the company is eyeing up to 1,000 layoffs, according to a report from STAT.

Biogen did not immediately respond to a request for comment.

Following FDA approval of the drug in June, BIIB shares soared to a record high. However, its stock has fallen steadily since then. BIIB shares are now trading at $232.62, 4.25% down from the beginning of the year.

As of October, the drug had spurred $2 million in sales and only $300,000 of that sum was in the third quarter.

Biogen developed Aduhelm in concert with Eisai (TYO:4523).

Between June to present, Adhelm has faced several setbacks. The approval of the drug has attracted federal investigations. In August, the Department of Veterans Affairs (VA) decided not to include Aduhelm in its drug formulary. In November, the European Medicines Agency (EMA) gave the marketing authorization application for Aduhel…

U.S. insurers hesitant to cover aducanumab

Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.”

Humana Inc. is, however, covering Aduhelm for patients who are similar to those in the drug’s clinical trials.

Having won conditional FDA approval in June, aducanumab has failed to gain traction as a popular therapy.

Biogen developed the drug in collaboration with Eisai Co., Ltd. (Tokyo, Japan).

The drug has received a flurry of negative headlines in recent months.

FDA called for an OIG investigation into its own dealings when reviewing the drug, and two House committees have launched investigations into its approval as well.

This week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHM…

EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab

Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.”

The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December 13-16.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Dr. Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen, in a press release.

In the U.S., aducanumab has seen several setbacks in recent months.

In August, the Department of Veterans Affairs (VA) decided not to include aducanumab in its drug formulary. The VA…