Tag: Aduhelm

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 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 […]

December 30, 2022

The document produced by Oversight and Reform Committee chair Carolyn Maloney (D-NY) and Energy and Commerce Committee chair Frank Pallone Jr (D-NJ) also points to “collaboration” between Biogen and the FDA ahead of an advisory committee meeting that nevertheless resulted […]

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 […]

January 12, 2022

In a highly unusual decision for a therapy approved by FDA, the Centers for Medicare and Medicaid Services (CMS) took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab). The CMS National Coverage Determination […]

January 12, 2022

Biogen and partner Eisai had been hoping for good news from the review of Aduhelm (aducanumab) by the Centre for Medicare and Medicaid Services (CMS), but the draft decision means broad coverage of the drug will have to wait for […]

December 27, 2021

Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been granted a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s approved therapy Aduhelm, which […]

December 20, 2021

The price reduction for Aduhelm (aducanumab) comes into play from 1 January and comes on the back of the “feedback of our stakeholders,” said the biotech’s chief executive Michel Vounatsos. “Too many patients are not being offered the choice of […]

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 […]

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 […]

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 […]