Aduhelm® (aducanumab-avwa)

BL 761178

Aduhelm® (aducanumab-avwa)

BL 761178

U.S. License Holder:

Biogen Inc.

Date of License:

June-07-2021

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ADUHELM (aducanumab-avwa) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:20-cv-10543 (D. Mass.)

U.S. Patent Nos.
8,906,367 (Method of Providing Disease-Specific Binding Molecules and Targets)

Plaintiffs
Biogen, Inc.; University of Zurich

Defendants
Creative Biolabs Inc.

Status
Dismissed Due to Settlement

BPCIA
N

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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