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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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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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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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…

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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…

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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…

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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…

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VA shies away from Biogen’s Aduhelm

The Department of Veterans Affairs (VA) will not include Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) controversial Alzheimer’s drug Aduhelm (aducanumab) in its drug formulary, citing what it deemed to be unclear efficacy paired with a significant risk of adverse events. 

The department’s pharmacy benefit manager advised against providing the drug given “the lack of evidence of a robust and meaningful clinical benefit and the known safety signal,” according to Endpoints News. 

The VA also added Aduhelm to its non-promotable list, which forbids pharmaceutical sales reps from promoting the drug to the VA. 

The list price for Aduhelm is approximately $56,000 annually. 

The VA, however, included aducanumab in the ‘Place in Therapy’ section of its national drug monograph, which provides an assessment of the drug’s clinical evidence. The document concluded that the VA “recommend[s] against offering this agent to patients with Alzheimer’s dementia (mild o…

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HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. 

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

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Aducanumab continues to face scrutiny as Biogen aims to woo neurologists and Alzheimer’s patients

Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism.

Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according to research from Spherix Global Insights.

Still, many neurologists are receiving a flood of queries about Aduhelm. “We’ve received a lot of inquiries from patients themselves, a lot more referrals from primary care doctors, geriatrics doctors, internal medicine doctors who actually have no idea what aducanumab is, and they just are referring a bunch of patients themselves,” said private-practice neurologist Dr. Roni Sharon in a briefing note with UBS analysts.

Demand for an effective Alzheimer’s treatment is considerable. “Family members have been coming in inquiring about the medi…

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