Category: aducanumab

Biogen adds real-world test for Aduhelm to its confirmatory trial

aducanumab, Aduhelm, alzheimer's disease, Biogen, Eisai, News, R&D, real word evidence / July 30, 2021 July 30, 2021

Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within the …

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FDA staffers defend Aduhelm approval in JAMA editorial

aducanumab, Aduhelm, alzheimer's disease, Biogen, central nervous system, Eisai, FDA, neurology, News, regulatory / July 14, 2021 July 14, 2021

Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that to do otherwise would have left millions of patients in limbo for years. The trio say that the decision to approve Aduhelm (aducanumab) was extremely challenging as “evidence was strongly …

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Consumer group seeks resignation of top FDA staffers over Aduhelm okay

aducanumab, Aduhelm, alzheimer's disease, Biogen, central nervous system, FDA, Janet Woodcock, Market Access, neurology, News, senior management / June 16, 2021 June 16, 2021

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director …

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Aducanumab (Aduhelm) for Alzheimer’s Disease

aducanumab, Aduhelm, alzheimer's disease, Donepezil, Galantamine, Memantine, Rivastigmine / June 15, 2021 June 15, 2021

Date: July 12, 2021 Issue #: 1628 Summary: Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer’s disease. The approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain. The manufacturer is required to conduct an additional …

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And then there were three: another FDA adcomm member quits over Aduhelm

aducanumab, Aduhelm, alzheimer's disease, Biogen, central nervous system, FDA, Market Access, neurology, News / June 11, 2021 June 11, 2021

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest. The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David …

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Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

aducanumab, Aduhelm, Alzheimer's, amyloid, Biogen, central nervous system, FDA, Market Access, neurology, News, regulatory / June 10, 2021 June 10, 2021

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 …

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

aducanumab, Aduhelm, alzheimer's disease, Biogen, drug pricing, FDA, ICER, Market Access, neurology, News / June 8, 2021 June 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s …

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

aducanumab, Aduhelm, alzheimer's disease, amyloid, Biogen, FDA, Market Access, neurology, News / June 7, 2021 June 7, 2021

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 …

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FDA grew too close to Biogen during Alzheimer’s drug development, doctors say

aducanumab, Alzheimer's, Biogen, Eisia, neurology, News, R&D / April 1, 2021 April 1, 2021

The FDA got too close to Biogen during the development of the Alzheimer’s drug aducanumab, according to its own expert advisers who are urging the regulator to reject it in the coming weeks. With the deadline for a regulatory decision approaching for aducanumab in June, three doctors who took part in the expert advisory board …

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Biogen shares soar as FDA delays decision on aducanumab

aducanumab, Alzheimer's, FDA, neurology, News, R&D / February 1, 2021 February 1, 2021

The FDA has delayed its decision on aducanumab, the troubled Alzheimer’s drug from Biogen and Eisai by three months, raising hopes that it could be approved after all. Biogen’s share price jumped considerably after the news broke at the back end of last week, as an FDA rejection had been on the cards after an …

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

aducanumab, alzheimer's disease, amyloid, Biogen, donanemab, Eisai, Eli Lilly, neurology, News, R&D / January 14, 2021 January 14, 2021

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, …

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Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

(BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, regulatory, reports / December 11, 2020 December 11, 2020

Shots: The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline …

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FDA panel unimpressed with data for Alzheimer’s drug aducanumab

aducanumab, alzheimer's disease, amyloid, Biogen, FDA, Market Access, neurology, News / November 9, 2020 November 9, 2020

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 …

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The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

aducanumab, advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, regulatory, reports, Study, Updates, Us FDA / November 9, 2020 November 9, 2020

Shots: The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab The committee voted 5-0 and …

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FDA advisory panel vote against approving Biogen’s drug for Alzheimer’s

aducanumab, advisory panel, alzheimer's disease, Biogen, BioPharma, biopharma nl, Daily, Eisai, FDA approvals, News, Pharma, Rhode Island, SYN, Top Story / November 6, 2020 November 6, 2020

The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.

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

aducanumab, alzheimer's disease, amyloid, Biogen, EMA, FDA, Market Access, News / November 3, 2020 November 3, 2020

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 …

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Biogen’s shares surge again as FDA hurries Alzheimer’s drug review

aducanumab, Alzheimer's, Biogen, News, R&D / August 10, 2020 August 10, 2020

Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. The FDA reserves these quick reviews for drugs that have the potential to improve care standards for serious diseases. There have been no new drugs approved for …

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Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it

aducanumab, alzheimer's disease, Amyloid beta, Biogen, BioPharma, biopharma nl, Cambridge, Daily, Eisai, FDA, Massachusetts, SYN, Tokyo, Top Story / August 7, 2020 August 7, 2020

Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.

Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

Abeta, aducanumab, alzheimer's disease, Amyloid beta, Biogen, BioPharma, biopharma nl, Cambridge, Daily, Eisai, Massachusetts, SYN, Top Story / July 8, 2020 July 8, 2020

The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug’s clinical benefit.