The agency approved Leqembi to be dosed every four weeks via IV as a maintenance therapy. The drug is already approved for the treatment of Alzheimer's for patients with cognitive impairment or ...

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...

Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance dosing regimen that would reduce the number of intravenous infusions needed to one per month.

Two widely touted Alzheimer’s drugs have been shown to enable patients to remain in their homes for longer periods of time.

The EU development comes shortly after Eisai and Biogen were given approval for a new once-monthly intravenous maintenance dose of Leqembi in the US, after a biweekly IV initial induction course ...

FY24 EPS is projected at $16.34. The FDA approved maintenance dosing regimen for Leqembi in Alzheimer's, while Biogen's nusinersen higher-dose regimen is under review. Our government trade tracker ...

However, in July 2023, new dementia drug Leqembi (lecanemab) received full approval from the Food and Drug Administration (FDA) on the basis of an 18-month, double-blind, phase 3 clinical trial ...

Leqembi is a Aβ monoclonal antibody that preferentially binds to toxic protofibrils (soluble Aβ aggregates), in addition to targeting and reducing Aβ plaques (insoluble Aβ aggregates).

Naito emphasized significant milestones for LEQEMBI, including its approval for IV maintenance dosing in the US, which reduces treatment frequency and is expected to enhance patient and ...

The milestone was reached as sales of Leqembi reached €200 million in Eisai fiscal year 2024 (April 2024 - Match 2025). The event entitles BioArctic to a €10 million payment. Leqembi is the ...

Recently, Biogen announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered AD drug, Leqembi. Post the FDA approval, patients have the option ...

Future of Healthcategory· January 27, 2025 US FDA OKs monthly maintenance dosing for Eisai ... Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday.