Aduhelm

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Aduhelm aducanumab-avwa

In the graph: 13 of 24 documents (939 of 1,090 pages); the rest are queued.

Application: BLA 761178
Sponsor: Biogen
Drug class: Anti-amyloid antibody
First approved: June 7, 2021

FDA decisions

June 7, 2021 Aduhelm, accelerated approval Accelerated approval

Also anti-amyloid antibodys: Leqembi, Kisunla, Leqembi Iqlik

From FDA documents. Not medical advice.

Anti-amyloid antibody

Aduhelm aducanumab-avwa
Leqembi lecanemab-irmb
Kisunla donanemab-azbt
Leqembi Iqlik lecanemab-irmb, subcutaneous

Regulatory records

Cholinesterase inhibitor

Cognex tacrine hydrochloride
Aricept donepezil hydrochloride
Exelon rivastigmine tartrate
Razadyne galantamine hydrobromide
Aricept ODT donepezil hydrochloride
Razadyne ER galantamine hydrobromide
Adlarity donepezil hydrochloride
Zunveyl benzgalantamine gluconate

NMDA receptor antagonist

Namenda memantine hydrochloride
Namenda XR memantine hydrochloride

Amyloid PET imaging agent

Amyvid florbetapir f-18
Vizamyl flutemetamol f-18
Neuraceq florbetaben f-18

Combination

Namzaric donepezil hydrochloride; memantine hydrochloride

Atypical antipsychotic

Rexulti brexpiprazole

Tau PET imaging agent

Tauvid flortaucipir f-18

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