Tag: Alzheimer’s Drug

July 3, 2024

The US regulator has cleared donanemab as Kisunla for use in patients with mild cognitive impairment or the mild dementia stage of Alzheimer’s with confirmed amyloid plaques, becoming the third drug in the class after Eisai/Biogen’s short-lived Aduhelm (aducanumab) and current rival Leqembi (lecanemab). The Alzheimer’s […]

June 11, 2024

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 […]

May 15, 2024

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 […]

March 8, 2024

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 […]

June 7, 2023

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, […]

February 23, 2023

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 […]

February 15, 2023

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 […]

January 20, 2023

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 […]

January 9, 2023

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 […]

July 6, 2022

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 […]

February 3, 2022

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 […]

November 17, 2021

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 […]

November 12, 2021

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. […]

September 28, 2021

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 […]

July 23, 2021

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 […]

June 25, 2021

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 […]

May 13, 2021

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 […]

January 29, 2021

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 […]

August 7, 2020

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 […]