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Biogen Treatment For Alzheimer’s

Benefits Must Be Confirmed

FDA approves Biogen Alzheimer’s treatment

Dr. Jason Karlawish, co-director of the Penn Memory Center in Philadelphia and a site investigator for Biogen’s clinical trials of the drug, disagreed with the FDA’s decision.

“It’s going to present a real challenge for patients and caregivers and clinicians about whether to prescribe the drug,” he said. It’s going to also present challenges for researchers who are conducting trials and are planning trials to develop better drugs.”

Still, Karlawish said he would prescribe aducanumab, but only “after having had a conversation with the patient and family members about the notable uncertainties that surround whether the drug even works.”

The new drug, which Biogen developed with Japans Eisai Co., did not reverse mental decline, only slowing it in one study.

The FDA is requiring the drug maker to conduct a follow-up study to confirm the drugs benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.

The drug will cost $56,000 a year, according to Biogen. The drug is given as an infusion every four weeks at a cost of $4,312 per infusion, based on the average weight of a patient with mild cognitive impairment or mild dementia.

Aducanumab aims to help clear harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have done that before but they made no difference in patients ability to think, care for themselves or live independently.

Am I Eligible To Receive Aducanumab

The clinical trials of aducanumab studied a limited, specific group of people. You may be eligible to receive the drug if you:

  • Are younger than 85 years old
  • Have confirmed mild cognitive impairment, defined as a mild decrease in memory and/or thinking that occurs daily but does not yet affect functioning
  • Have amyloid present in the brain
  • Do not have a history of microbleeds, transient ischemic attacks, or stroke due to bleeding
  • Do not take blood-thinning medications

Next In The Dementia Drug Pipeline

For the handful of other developmental Alzheimer’s drugs hoping to clear those same regulatory hurdles and prove their efficacy Eli Lilly‘s donanemab, Roche’s gantenerumab and Eisei’s lecanemab among them there may be a silver lining to ceding first-mover advantage to Aduhelm.

After decades of expensive but thus far largely fruitless research trials, the CEO of pharma giant Eli Lilly, David Ricks, said his firm was “getting closer and closer to the goal” after a positive set of Phase Two results for its offering, donanemab.

Speaking at CNBC’s Healthy Returns Summit in May, a month before the FDA’s approval for rival Biogen’s Aduhelm, he said his team felt “good about the probability of success,” and said he wanted to explore an “accelerated” route too, using what he called “adaptative pathways at the FDA to consider looking at data sooner” that “should be applied in a serious and widespread condition like Alzheimer’s.”

However, he acknowledged that recruitment for the next phase of trials required a significantly larger cohort of participants, and given that it would last 18 months, he did not expect a new approved product before late 2023 at the earliest.

Several experts told CNBC the Biogen drug’s unique threshold for regulatory approval, with treatment potential seeming to trump uncertain real-world benefits, could reinvigorate efforts by competitors like Lilly, who are focused on developing drugs that rely on relatively similar techniques.

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A Case For Fda Approval: Biogens Aducanumab

Time kills deals, as the saying goes. And the biggest deal on the Alzheimers frontin terms of improving cognition in the early stages of the diseaseis Biogens new drug aducanumab, currently under review by the Food and Drug Administration for approval. If approved, aducanumab would be the first-ever drug to slow the progression of Alzheimers and first-ever drug to treat mild cognitive impairment. Early-stage Alzheimers has not been afforded a new approved therapy in more than 17 years. No other major disease of Alzheimers scale and mortality has gone that long without incremental therapeutic relief.

George Vradenburg, the UsAgainstAlzheimers chairman and co-founder, testified last fall at an FDA panel considering the merits of aducanumab, If we wait for the perfect drug or perfect data, we will descend further into the grip of this awful diseasePeople staring into the abyss of Alzheimers deserve no less. I joined this battle against Alzheimers because my family has experienced three generations of Alzheimers over 40 years. At this pace, my children and grandchildren are in the Alzheimers bulls-eye.

The FDA is now considering the panels opinions regarding aducanumab. While a decision had been expected by early March, the FDA has extended its review March until June. It could approve this new disease-modifying therapy for use, or it could require additional clinical trials and studies that could delay approval for several more years.

Time kills deals

What Are The Possible Side Effects Of Aducanumab

Biogen Shares Soar After Announcing Alzheimer

The most common side effects include areas of brain swelling, small brain bleeding, headache, or falls. The areas of brain swelling and small brain bleeding are usually temporary and resolve over time. Everyone who receives aducanumab will have periodic MRIs to monitor for these side effects, which can cause headache, confusion, dizziness, vision changes, or nausea but may not cause any symptoms.

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Biogens Investigational Alzheimers Disease Treatment Aducanumab Granted Fda Fast Track Designation

Company Also Provides Update On New Interim Analysis From Phase 1b Study

CAMBRIDGE, Mass.—-Today Biogen announced that aducanumab, its investigational treatment for early Alzheimers disease , was granted Fast Track designation by the U.S. Food and Drug Administration . The FDAs Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimers disease.

By collaborating with regulators through programs like Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimers disease as quickly as possible, said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen.

Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimers disease.

For more information about the Phase 3 studies, including information about participating centers, visit www.ClinicalTrials.gov .

Update: Phase 1b DataPRIME is the ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics , pharmacodynamics and clinical effects of aducanumab in patients with prodromal or mild AD.

Biogen And Eisai Amend Collaboration Agreements On Alzheimers Disease Treatments

  • Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective January 1, 2023.
  • Lecanemab collaboration to continue unchanged globally
  • Lecanemab supply agreement to extend to 10 years from 5 years for commercial manufacturing by Biogen
  • Both companies will continue to collaborate together with the goal of bringing more options to patients and maximizing the value of both products

The companies will continue to jointly develop and commercialize the investigational therapy lecanemab. Eisai continues to serve as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. Both companies share economics equally with Eisai booking all sales for lecanemab and Biogen reflecting its 50% share of profits and losses. The supply agreement related to lecanemab has been extended from five to 10 years. Biogen will manufacture the lecanemab drug substance in its Solothurn, Switzerland facility with the goal of providing reliable commercial supply worldwide.

About Biogen

The company routinely posts information that may be important to investors on its website at www.biogen.com. To learn more, please visit www.biogen.com and follow Biogen on social media , , , .

About Eisai

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The Drug Has Sold Poorly Since Its Approval In June Due To Concerns About Its Safety Effectiveness And Cost

Biogen Inc. is slashing in half the price of its controversial new Alzheimers disease treatment, Aduhelm, in a bid to revive a product launch that has stalled in part because of a backlash over the drugs cost.

The price cut will reduce the average annual cost of treatment to $28,200 a patient from the $56,000 the company set when the drug was approved in June, Biogen said Monday.

Ticker
+0.83 +0.41%

Biogen, whose shares have been hurt by Aduhelms poor performance, also said it planned to cut costs by about $500 million, though it is working out the details of the cuts.

Aduhelm is the first new treatment for Alzheimers disease in nearly two decades, but it has been sparingly prescribed, in large part because health insurers are reluctant to pay for it.

“Too many patients are not being offered the choice of Aduhelm due to financial considerations and are thus progressing beyond the point of benefiting from the first treatment to address an underlying pathology of Alzheimers disease,” Biogen Chief Executive Michel Vounatsos said.

This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm.

“We hope our actions today will facilitate patient access to these innovative Alzheimers treatments,” Mr. Vounatsos said.

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Biogen shares fall after it scraps Alzheimer’s treatment

Biotech giant Biogen said Thursday that it brought in about $1.6 million in sales from its controversial Alzheimers drug last month after it was approved by the Food and Drug Administration earlier in June.

The drug, which is marketed as Aduhelm, is the first new treatment for Alzheimers in about 18 years and the first that doctors are hoping will not just lessen symptoms but target the underlying disease.

The company said in its second-quarter earnings report that the drug, which was approved by the FDA on June 7, did $1.6 million in sales before the end of the quarter, which was June 30.

The companys revenue from Aduhelm is modest now, but the drug has just recently been rolled out. The company reported total revenue of almost $2.8 billion for the quarter, down 25 percent from a year earlier.

The company said it expects Aduhelm to continue to contribute modest revenue this year, with a ramp-up thereafter.

Biogen has slapped a $56,000-per-year price tag on Aduhelm, outraging some Alzheimers advocates and even raising questions among Wall Street analysts.

The drugs approval by the FDA brought hope to the more than 6 million Americans living with Alzheimers although some doctors objected to the approval, saying theres not enough evidence to show its actually effective.

Three scientists on a panel advising the FDA reportedly resigned after the drugs approval.

Despite concerns, last month a Rhode Island man became the first patient to get a transfusion of the drug.

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What The Data Show

The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint. In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.

We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.

Healthis The Key To Alzheimer’s Disease Brain Inflammation

The FDAs review of the drug has become a flashpoint in long-standing debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimers patients and their families say any new therapy even one of small benefit warrants approval. But many experts have warned that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.

The approval came despite the scathing assessment in November by the FDAs outside panel of neurological experts. The group voted no to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed that the drug was effective.

Cambridge, Massachusetts-based Biogen halted two studies of the drug in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients. Several months later, the company reversed course, announcing that a new analysis of one of the studies showed the drug was effective at higher doses and that the FDA had advised that it warranted review. Company scientists said the drugs initial failure was due to some patients not receiving high enough doses to slow the disease.

But the changes to dosing and the companys after-the-fact analysis made the results hard to interpret, raising the skepticism of many experts, including those on the FDA panel.

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Large And Longer Trials

These findings allowed Biogen to conduct larger clinical trials of Aducanumab. Two trials, called ENGAGE and EMERGE, collectively enrolled over 2,500 people with MCI or early-stage dementia caused by Alzheimers disease.

The changes in the brain caused by Alzheimers disease tend to start many years before symptoms show. This means that earlier treatment is likely to have a better chance of being effective. The main aim of the ENGAGE and EMERGE trials was to see if Aducanumab could reduce signs of cognitive decline in the people with MCI and mild dementia. Participants received different doses of the drug and were compared to people receiving a placebo treatment. The placebo contained no active ingredient.

The two large Aducanumab trials began in 2015 but were cut short in March 2019. Although the EMERGE trial was said to be trending positive in terms of potential outcomes, early results indicated the ENGAGE study was not going to be successful. In order to progress, Biogen had specified that both trials needed to be heading in the right direction. The results meant that both trials were terminated.

New Alzheimers Treatment Is Giving Families Hope Doctor Says

Biogen Shares Soar After Announcing Alzheimer

In the case of Aduhelm, the surrogate endpoint was reduction of amyloid plaque in the brain, clumps of protein that are considered a hallmark of the disease. Reduction of these plaques “is reasonably likely to predict clinical benefit of the drug,” she said.

But saying a drug is reasonably likely to predict clinical benefit does not mean it is guaranteed to do so. Because of this, drugs approved through the FDA’s accelerated pathway must continue to study the drug to confirm its clinical benefits.

“If the clinical benefit is not confirmed, or if the study is not conducted in a timely manner, we may withdraw this therapy’s approval,” Cavazzoni said.

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Biogen: Alzheimers Treatment Could Be A Great Success

Biogen had a disappointing performance recently, dropping more than 35% over the last six months, in line with the healthcare sector.

Biogen is a drugmaker working on innovative therapies to treat people with serious neurological diseases such as multiple sclerosis and Alzheimers.

The study of potential factors that trigger cognitive impairment has led to some scientific breakthroughs that could bring a breath of fresh air to Biogens portfolio, as its treatments seem a little lazy from a profitability standpoint. This leads to a hopeful bullish stance on this stock.

Debate Over Targeting Beta Amyloid Formations

Known among scientists as aducanumab, it works by offering an array of identical antibodies that are cloned from white blood cells. These antibodies are chosen for their targeting abilities, since they can identify specific proteins, called beta amyloids, that have constructed particular formations in the body.

There is extensive evidence suggesting that these beta amyloid formations, also known as “pathological aggregates” or “plaques,” are a major driver of Alzheimer’s disease, though the exact causal mechanisms are still not fully understood, according to Christian Pike of USC’s Leonard Davis School of Gerontology. Nonetheless, he says the antibodies can help prevent these plaques from forming, before directing other particles to break them apart, a process that’s clearly identifiable in before-and-after neural imaging.

For an analogy, it may be helpful to think of the beta amyloid proteins as young people walking around a city over the course of the day, where the city is the human body, and the day is a human lifespan. In certain cities, as afternoon turns into evening, individual young people start to congregate, and some of those congregations can turn toxic, and begin to cause problems. The antibodies delivered by Aduhelm act like law enforcement officers, arriving on the scene, identifying troublesome gatherings, surrounding them, separating them, then ordering bystanders to make the young people disperse.

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Biogen’s Alzheimer’s Treatment Is Approved By Fda Stock Soars

Saying the benefits outweighed the risks, the Food and Drug Administration on Monday approved aducanumab, Biogen’s highly anticipated Alzheimer’s disease drug.

The approval is for aducanumab, which will be marketed under the name “Aduhelm.” The decision makes the drug the first new treatment for Alzheimers disease in nearly two decades.

Biogen partners on the drug with Japan’s Eisai.

“This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003,” the FDA said in a statement. “Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.”

The FDA said the clinical trials for Aduhelm “were the first to show that a reduction in these plaques – a hallmark finding in the brain of patients with Alzheimer’s – is expected to lead to a reduction in the clinical decline of this devastating form of dementia.”

The agency said it ultimately decided to use the Accelerated Approval pathway, which is “intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.”

In January, analysts reacted positively to the FDAs decision to extend by three months the review period for aducanumab.

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