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Report: Congressional committees have questions over Biogen’s Alzheimer’s drug

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug.

According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by Sept. 16, having told the agency that the information “was helpful, but significant questions remain.”

Last month, the HHS Office of Inspector General said it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen and Eisai. FDA officials went on to defend the use of the accelerated approval pathway in correspondence in NEJM, arguing that amyloid reduction is a “reasonably likely” surrogate.

The committees requested information regarding the …

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…

Why FDA’s approval of aducanumab was unprecedented

The backlash surrounding aducanumab post-approval has put Biogen (NSDQ:BIIB) on the defensive, prompting the company’s head of research and development, Dr. Alfred Sandrock, to post an open letter to the Alzheimer’s disease community on Biogen’s website. In the letter, Sandrock lamented that there was “extensive misinformation and misunderstanding” regarding the drug.

In recent weeks, the company also requested that the FDA narrow the indication for the drug to focus on Alzheimer’s patients with mild cognitive impairment or mild dementia. The FDA had initially indicated it for all Alzheimer’s patients even though clinical trials focused on patients with milder forms of the disease.

The collaboration between FDA staff and Biogen

FDA closely worked with Biogen during the approval process of aducanumab. Critics such as Public Citizen have called the cooperation between the two organizations “unprecedented” and “inappropriately close.”

FDA had viewed data fr…

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…

Lilly’s donanemab could outclass aducanumab, but questions remain

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.

But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.

Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

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Senate Finance committee senators call for hearing on Medicare coverage of aducanumab

Photo by Thuan Vo from Pexels

Senate finance committee members Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) are pushing to have a hearing to discuss the Medicare coverage of Aduhelm (aducanumab), Biogen’s controversial Alzheimer’s treatment, which recently won FDA approval.

In a letter addressed to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), Warren and Cassidy express concern that the drug could cost Medicare $37 billion to $90 billion annually. “This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency,” they wrote.

The letter also recommends that Medicare consider limiting the use of the drug to patients most likely to benefit from it. The clinical trials for aducanumab focused on Alzheimer’s patients with mild cognitive impairment.

Biogen has yet to provide rig…

Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

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