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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…

Biogen slashes Aduhelm cost in half

Biogen (NSDQ:BIIB) has announced that it is cutting the wholesale acquisition cost of the controversial Alzheimer’s drug Aduhelm (aducanumab) by roughly half.

Starting January 1, 2022, the annual cost for a 100 mg/mL injection of the drug will be $28,200 for a patient who weighs 74 kg (163 pounds).

In related news, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on approving Aduhelm. Biogen is asking for a reexamination of the decision.

BIIB shares fell 1.13% to $234.74 in mid-day trading.

Biogen and its partner Eisai (TYO:4523) have faced a string of setbacks related to the drug after it won FDA approval. As a result, sales of the drug have been weak.

“Over the past several months, we have listened to the feedback of our stakeholders, and we are now taking important actions to improve patient access to ADUHELM,” said Michel Vounatsos, CEO at Biogen, in a stateme…

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…

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…

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.”

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.”

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…

Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.

The company’s stock dropped 6.79% to $328.16.

After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials. FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug. Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal.

The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment a…

Medicare evaluating Aduhelm coverage while Democrats ask Biogen for documents
While CMS is mulling potential coverage of the Alzheimer’s drug, Democrats are seeking information on the approv

As Medicare officials review evidence about Biogen’s (NSDQ:BIIB) Aduhelm (aducanumab) to determine if and how it will cover the drug, two high-level House Democrats are asking Biogen about its dealings with FDA.

Yesterday, Carolyn Maloney (D-N.Y.) and Frank Pallone, Jr. (D-N.J.) sent a letter to Biogen CEO Michel Vounatsos asking for details about the company’s communications with FDA staff before it filed a Biologics License Application for aducanumab. Maloney chairs the House Committee on Oversight and Reform, while Pallone chairs the House Committee on Energy and Commerce.

The House isn’t alone in its push for such information regarding the drug, which could cost patients $56,000 annually in out-of-pocket expense. Acting FDA Commissioner Dr. Janet Woodcock recently asked the Office of Inspector General to launch an independent review of the agency’s dealings with Biogen during the Aduhelm approval process.

Public Citizen recently filed a letter to C…

FDA narrows indication of Biogen’s aducanumab

After FDA approved Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Aduhelm (aducanumab) to treat Alzheimer’s disease, the agency faced criticism that the indication was overly broad. While initially indicating aducanumab for all Alzheimer’s patients, the agency has decided to recommend it for patients with mild forms of the disease.

The EMERGE and ENGAGE Phase 3 studies for the drug involved patients with early Alzheimer’s disease.

The revised label recommends the use of the drug in patients with “mild cognitive impairment or mild dementia stage of disease.”

The revised label points out that there are no safety or effectiveness data for people with “earlier or later stages of the disease than were studied” in the Phase 3 trials.

The update came after Biogen’s head of R&D, Dr. Alfred Sandrock, requested that the agency incorporate feedback from physicians and the Alzheimer’s community.

Critics have also lamented that the prospect of mak…