Category: amyloid

  • Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

    The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to slow cognitive decline in patients with an inherited form of the disease. The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with […]

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

    Here we go again. 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. The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA […]

  • CMS decision on Aduhelm is in, and it’s bad news for Biogen

    The US Centres for Medicare and Medicaid Services (CMS) has firmed up its draft decision to limit reimbursement of Biogen’s Alzheimer’s disease therapy Aduhelm to a few thousand patients enrolled in clinical trials. The final verdict from the CMS dashes any remaining hopes that Biogen may have held that it would be able to build […]

  • Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

    Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote against doing so. Washington University neurologist Joel Perlmutter was the first to announce he was stepping down from the Peripheral and Central Nervous System Drugs Advisory Committee on the day […]

  • Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab

    Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The accelerated approval from the US regulator has been given even though its own advisory committee comprehensively voted down the main study filed in support of the drug last […]

  • Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?

    When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, […]

  • FDA panel unimpressed with data for Alzheimer’s drug aducanumab

    The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking. The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved to be a fractious affair, with both the companies’ data […]

  • Trials and tribulations in Biogen’s Alzheimer’s drug reviews

    Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data behind the drug is strong enough to support approval. The EMA has just kicked off its review of the anti-amyloid therapy, following in the footsteps of the FDA in the […]