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Tag: Alzheimer’s Drug


FDA, Regulations

FDA Advisors Support New Alzheimer’s Drug, Donanemab

June 11, 2024

Via: Drugs.com

A U.S. Food and Drug Administration advisory panel voted unanimously on Monday to recommend that the benefits of a new drug for Alzheimer’s outweigh its harms, which can include brain swelling and bleeding. Eli Lilly’s donanemab did slow declines in thinking skills […]


FDA, Regulations

Biogen and Eisai announce rolling FDA submission for injectable version of Alzheimer’s drug

May 15, 2024

Via: PMLiVE

Leqembi (lecanemab-irmb) was granted traditional approval in the US in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment or early-stage Alzheimer’s disease. The Leqembi SC autoinjector has already been granted Fast Track designation […]


FDA, Regulations

FDA Delays Decision on New Alzheimer’s Drug

March 8, 2024

Via: Drugs.com

Instead of approving the new Alzheimer’s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the drug’s maker said Friday. “The FDA […]


FDA, Regulations

Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi

June 7, 2023

Via: Biopharma Dive

A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it. The medicine, known scientifically as lecanemab and commercially as Leqembi, […]


News

Medicare maintains limits on Eisai’s new Alzheimer’s drug

February 23, 2023

Via: Biopharma Dive

The CMS issued its statement late Wednesday following a request from the Alzheimer’s Association to reconsider its coverage policy on amyloid-clearing antibody drugs. The agency said its standards for coverage, that a drug is “reasonable and necessary,” differ from the […]


FDA, Regulations

Safety-related change to label for Biogen’s Alzheimer’s drug Aduhelm approved by FDA

February 15, 2023

Via: PMLiVE

The new label states that physicians prescribing the drug should ‘inform patients that events of intracerebral haemorrhage greater than 1cm in diameter have been reported infrequently in patients taking Aduhelm, and that the use of antithrombotic or thrombolytic medications while […]


FDA, Regulations

FDA rejects Lilly Alzheimer’s drug, citing insufficient data

January 20, 2023

Via: Biopharma Dive

The Food and Drug Administration has rejected an experimental Alzheimer’s disease drug being developed by Eli Lilly, denying an attempt by the Indianapolis-based pharmaceutical company to secure accelerated approval for the medicine. In issuing a so-called complete response letter, the […]


Pricing, Regulations

Alzheimer’s drug Leqembi to launch at discount to Aduhelm

January 9, 2023

Via: Pharmaphorum

The US regulator has granted accelerated approval to anti-amyloid therapy Leqembi (lecanemab) with a fairly broad label to treat patients in the mild cognitive impairment or mild dementia stage of disease who have confirmed presence of amyloid pathology. Eisai and […]


FDA, News, Regulations

Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan

July 6, 2022

Via: Pharmaphorum

The US regulator has been reviewing lecanemab as a treatment for patients with early-stage Alzheimer’s and amyloid plaques in the brain under a rolling biologics license application which completed in May. The timeline puts lecanemab ahead of Lilly’s donanemab in […]


FDA, Regulations

Lilly slows FDA submission of Alzheimer’s drug after Medicare decision

February 3, 2022

Via: Biopharma Dive

Lilly’s announcement is a consequence of Medicare’s draft policy, which, if finalized later this year, would restrict coverage for Aduhelm and donanemab to people enrolled in randomized, placebo-controlled trials. Both drugs work by targeting deposits of a sticky protein, called […]


News

European drugs regulator signals rejection likely for Biogen’s Aduhelm

November 17, 2021

Via: Biopharma Dive

A European Medicines Agency panel voted against Biogen’s new Alzheimer’s drug Aduhelm at a recent meeting, indicating the controversial treatment could be rejected by the regulator next month. Biogen acknowledged the negative vote in a Wednesday statement and said it […]


Industry, Pharma

Cortexyme plans path forward for Alzheimer’s drug that failed study

November 12, 2021

Via: Biopharma Dive

Faced with the failure of a key clinical trial, a California-based biotech is pressing ahead with plans to test its experimental Alzheimer’s drug in another study, convinced that signs of benefit observed in some patients are proof its treatment works. […]


FDA, Regulations

Eisai, Biogen to test FDA by asking for approval of second Alzheimer’s drug

September 28, 2021

Via: Biopharma Dive

The Food and Drug Administration’s approval of Biogen’s Alzheimer’s drug Aduhelm in early June has become one of the most controversial and publicly acrimonious decisions in the agency’s recent history. In the nearly four months since, the decision has led […]


FDA, Regulations

Roche engaged in talks with FDA for Alzheimer’s drug candidate

July 23, 2021

Via: PMLiVE

CEO Severin Schwan told reporters on Thursday that Roche is in “a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be”. He also revealed that Roche is planning to complete […]


FDA, Regulations

Congressional Democrats launch probe into Biogen’s Aduhelm FDA approval, citing ‘serious concerns’

June 25, 2021

Via: FiercePharma

The rumblings on Capitol Hill over Biogen Alzheimer’s drug Aduhelm have been growing louder in recent days as lawmakers began speaking out about its lofty price tag and controversial FDA win. Now two high-ranking Democrats want answers. The House Committee […]


Clinical Trials, Research and Development

Exscientia starts trials of AI-designed Alzheimer’s drug

May 13, 2021

Via: Pharmaphorum

The new molecule – called DSP-0038 – is being developed by Japan’s Sumitomo Dainippon Pharma (DSP), which is now starting a phase 1 trial in the US as a treatment for psychosis associated with Alzheimer’s, and to see if it […]


Clinical Trials, FDA, Regulations, Research and Development

FDA delays verdict for Biogen’s closely watched Alzheimer’s drug, raising investor optimism

January 29, 2021

Via: Biopharma Dive

Aducanumab has taken one of the most winding paths of any drug in recent history. After going through initial clinical testing, Biogen pushed two doses of the drug into a pair of large, identically-designed studies meant to prove its merit […]


FDA, Regulations

FDA Accepts BLA for Biogen’s Alzheimer’s Drug, Grants Priority Review

August 7, 2020

Via: BioSpace

Shares of Biogen jumped more than 11% in premarket trading after the company announced the U.S. Food and Drug Administration accepted its Biologics License Application for aducanumab, an investigational treatment for Alzheimer’s disease. Not only did the regulatory agency accept […]