A bottle is seen in front of the Biogen logo displayed in this illustration taken December 1, 2021. REUTERS/Dado Ruvic/Illustration

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March 16 (Reuters) – Biogen Inc (BIIB.O) on Wednesday published long-awaited study results supporting approval of its Alzheimer’s disease drug in a lesser-known medical journal whose editor-in-chief was a chief leader in research, adding controversy to the already troubled treatment.

Data on the drug Aduhelm – the first treatment for mental illness to gain US approval in 20 years – was published in the Journal of Prevention of Alzheimer’s Disease, for which Dr Paul Aisen, who is also a second author on the studies, is editor.

The company has come under pressure to publish its findings to allow the wider scientific community to view the data. Biogen presented the studies earlier Wednesday at a meeting on Alzheimer’s disease in Barcelona.

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“It has always been our intention that our Phase 3 data be peer-reviewed to provide physicians with a better understanding of the appropriate use of Aduhelm, and we have been working urgently towards this end,” the door said. – Biogen spokesperson Ashleigh Koss in an emailed statement. .

She declined to comment on why the study was published in a lesser-known journal associated with one of the study authors.

Aisen in an email said he was not involved in the review of the research or the decision to publish, details which are listed in the disclosure section of the research document.

Biogen’s Aduhelm has been embroiled in controversy since the US Food and Drug Administration granted it fast-track approval even after its expert panel of outside advisers advised against it, saying there was no insufficient evidence of patient benefit.

The limited data published earlier showed that only one of Aduhelm’s two pivotal studies demonstrated a slowing of cognitive decline.

In an unusual move, the US Centers for Medicaid and Medicare Services (CMS), which runs the government’s health plan for people aged 65 and over, in January proposed paying for the drug only for patients enrolled in approved clinical trials, a decision that significantly limits patient access. Read more

Patient groups have lobbied CMS to change the policy, which includes similar drugs in development, saying it will delay treatment for Alzheimer’s disease for most people for many years. Read more

Biogen said on Wednesday that patients enrolled in its Aduhelm trials experienced reductions in two substances linked to memory disease after nearly two and a half years of treatment.

The company said Aduhelm “significantly reduced” beta-amyloid plaque levels through week 132 of treatment and also decreased plasma levels of a protein called p-tau181 at week 128.

The company said patients who, at week 78 of the trial, showed reduced plasma p-tau181 levels had less clinical decline in the extended trial than those whose plasma p-tau181 levels did not. had not been reduced earlier.

Beta-amyloid and tau protein make up the plaques and tangles in the brain that characterize Alzheimer’s disease. Reviewers said approval should be based on demonstrable patient improvements or slowing of cognitive decline rather than reductions in these secondary markers.

BMO analyst Evan David Seigerman in a research note called the data “minimally positive” but said it was unlikely to influence the government’s hedging plan.

Patient advocacy groups argue that new treatments for Alzheimer’s disease are desperately needed. The number of Americans with Alzheimer’s disease is expected to rise to 13.8 million by 2050, from more than 6 million currently.

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Additional reporting by Manojna Maddipatla in Bengaluru; Editing by Maju Samuel and Bill Berkrot

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