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In quiet debut, Alzheimer's drug finds questions, skepticism

Although the first Alzheimer's treatment approved by regulators in over 20 years was celebrated as a breakthrough, its rollout has been slowed down by questions about its cost and effectiveness.

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In quiet debut, Alzheimer's drug finds questions, skepticism

Many major medical centers are still undecided about whether or not to use Biogen’s Aduhelm. This is the recommended treatment for the early stages of the disease. Major medical centers like Mass General Brigham in Boston and the Cleveland Clinic have said they will not use it.

One neurology practice even expelled the company's sales representatives from its offices due to concerns about the drug's price and potential for it to rise past $50,000 per year.

Many doctors feel they must learn more about Aduhelm and the benefits before they offer it to patients. This could take many months. There may be questions that remain even after the process is completed.

Salim Syed, an analyst covering Biogen for Mizuho Securities USA, stated that "the drug won't work for everyone, even with access."

Syed estimates that around one-tenth (or less) of people with early-stage Alzheimer’s will end up taking Aduhelm regularly, particularly if regulators approve similar treatments by Biogen's rivals.

Biogen reports its third quarter financial results Wednesday. However, it doesn't say how many people have been given the drug since June 7. A company executive stated last month that Biogen knew of approximately 50 Aduhelm sites, which is far less than the 900 it had claimed to have in its possession shortly after the drug was approved by regulators.

Aduhelm is one of a number of new drugs that promises to slow down the progression of this fatal brain-destroying disease.

Dr. Stephen Salloway of Rhode Island, a neurologist and Biogen consultant, said that the drug is "like a breath-taking fresh air." Alzheimer's patients "know what's ahead, and they want everything they can do to stay in the milder stages."

Aduhelm was approved by the U.S. Food and Drug Administration despite objections from several independent advisors who have since resigned. Later, the agency stated that Aduhelm was suitable for patients with mild cognitive impairments or early-stage Alzheimer’s.

Aduhelm removes brain plaque believed to be linked to Alzheimer's disease. The decision was made by regulators based on research results that showed the drug would likely benefit patients.

Biogen, which co-developed Aduhelm with Japan’s Eisai Co. had to stop two studies due to disappointing results. Later, it said that further analysis had shown the treatment's effectiveness at higher doses.

Biogen is required by the FDA to perform a follow up study.

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