FDA approves much-debated Alzheimer's drug: All you need to know about Biogen Inc’s aducanumab
Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, adding that the price would not be raised for four years
The Food and Drug Administration approved the first new drug for Alzheimer’s disease in nearly 20 years, despite warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.
The Food and Drug Administration approved the drug from Biogen, likely to act as a treatment rather than managing symptoms like anxiety and insomnia, based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients.
Around 6 million people in the US and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.
The new drug to be sold under the brand Aduhelm, which Biogen developed with Japan’s Eisai Co, did not reverse mental decline, but only slowed it in the study.
Who is it for?
The FDA approved Aduhelm for the treatment of Alzheimer’s disease, but the patient population for whom the treatment is appropriate is yet to be defined, according to The Indian Express. The drug was tested in patients in the earliest stages of Alzheimer’s, but not in people who had progressed to moderate dementia, a stage in the disease in which patients start to lose the ability to care for themselves.
Biogen has estimated that around 1.5 million Americans are eligible for treatment with Aduhelm.
Alzheimer’s is estimated to account for at least 60 percent of dementia, according to the Alzheimer’s Association. But Aduhelm will likely be prescribed only after cognitive testing and confirmation establishes the dementia is due to Alzheimer’s.
What does it do?
Aducanumab helps clear a protein called beta-amyloid, which forms plaques in the brains of patients with Alzheimer’s disease. Amyloid is thought to begin forming years before any signs of memory loss appear, making treatment as early as possible most likely to provide benefit.
The drug is designed to slow the progression of Alzheimer’s disease, allowing patients to remain as self-sufficient as possible for as long as possible. However, it is not a cure.
Are there side effects?
The drug carries a warning about temporary brain swelling that can sometimes cause headaches, confusion and dizziness. Other side effects included allergic reactions, diarrhea and disorientation.
How is the drug administered?
Aducanumab is to be given as an infusion every four weeks and most patients will likely need to receive the treatment at specialty infusion centers. Biogen said in April that it was working with 900 US centers to prepare for the pending launch of the drug. The drug, manufactured from living cells, is expected to be prescribed by Alzheimer’s specialists.
Under terms of the so-called accelerated approval, the FDA is requiring Biogen to conduct a follow-up study to confirm 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.
How much does it cost?
Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. With FDA approval, aducanumab is almost certain to be covered by most insurers, including Medicare, the government plan for seniors that covers more than 60 million people. Insurers could try to manage the drug’s costs by requiring strict conditions, including brain scans to confirm plaque, before agreeing to cover it.
The company said it aims to complete the FDA-mandated follow-up trial by 2030. Patients may also have to pay part of the cost of diagnostic testing and tests for monitoring side effects.
The non-profit Institute for Clinical and Economic Review, which studies drug value, said Biogen’s drug would have to halt dementia entirely to justify its price tag.
Studies on drug were halted earlier
Biogen halted two studies 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 study showed the drug was effective at higher doses and the FDA had advised that it warranted review, according to reports.
Company scientists said the drug’s initial failure was due to some patients not receiving high enough doses to slow the disease. But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising skepticism among many experts, including those on the FDA panel.
The decision to approve this drug could impact millions of Americans and is certain to spark disagreements among physicians, medical researchers and patient groups.
Dr Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision. “The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” Alexander, a medical researcher at Johns Hopkins University, told The Associated Press.
With inputs from agencies
Though the causes of the disease are not completely known yet, India has almost a fourth of the world's Alzheimer`s patients, with doctors adding that underreporting is the biggest problem.
An active lifestyle helps preserve the brain's grey matter and lowers the risk of dementia and Alzheimer's disease (AD), says a new study.