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STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

STAT News

Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. Such decisions are based on myriad factors, starting with the average $26,500 price tag.

Drugs 119
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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.

Drugs 110
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Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

pharmaphorum

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA. Biogen and Eisai have another go appeared first on. Here we go again. The post Exit Aduhelm, enter lecanemab.

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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

Joint makers Biogen and Eisai decided to pull Aduhelm because of the continuing questions and lower-than-expected uptake by insurers and providers due to its high cost. Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4).

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Biogen updates on its confirmatory Aduhelm trial

pharmaphorum

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one.

Trials 52
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Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

Biogen developed aducanumab in partnership with Japanese pharmaceutical company Eisai. Aducanumab Controversy and Price Tag. Aducanumab is a human IgG1 monoclonal antibody that binds to aggregated forms of amyloid beta to help reduce its buildup. Evidence for aducanumab’s efficacy has been highly contested.

Drugs 98
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Viagra ‘should be tested as Alzheimer’s therapy’

pharmaphorum

That finding could provide some comfort to Biogen and Eisai, whose recently-approved amyloid-targeting drug Aduhelm (aducanumab) is struggling to gain traction in the market on the back of unconvincing efficacy data, safety concerns and a high price tag.

Drugs 52