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Lilly follows Biogen-Eisai in securing US FDA approval for Alzheimer's drug

FILE PHOTO: Lilly Biotechnology Center is shown in San Diego
July 03, 2024
Reuters - Reuters

(Reuters) - Eli Lilly's Kisunla secured standard approval from the U.S. Food and Drug Administration on Tuesday for slowing the progression of Alzheimer's disease.

Kisunla is now the second drug to get a traditional approval from the U.S. regulator for the brain-wasting disease after Biogen and Japan-based Eisai's Leqembi, marking a major milestone in a field that has witnessed multiple failures.

The following is a list of companies with approved therapies in the U.S. market and those currently developing treatments that aim to modify the memory-robbing disease:

Lilly follows Biogen-Eisai in securing US FDA approval for Alzheimer's drug
The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo

Company Drug or Stage of Mechanism

Therapy development &

indication

Eli Lilly

Lilly follows Biogen-Eisai in securing US FDA approval for Alzheimer's drug
A sign marks a Biogen facility in Cambridge

and Co Kisunla Secured U.S. FDA's Designed to

target and

standard approval remove toxic

for protein plaque

Lilly follows Biogen-Eisai in securing US FDA approval for Alzheimer's drug
Handout image shows Alzheimer's drug LEQEMBI

early Alzheimerโ€™s in the brain

known as

beta-amyloid to

slow down

cognitive

decline

The An

Eisai Co Leqembi first Alzheimerโ€™s antibody

Ltd & treatment to designed to

Biogen Inc win remove sticky

beta-amyloid

standard approval deposits from

from the U.S. FDA the brain

BioVie NE3107 An oral small

Late-stage trial molecule that

for aims to inhibit

mild-to-moderate neuroinflammati

Alzheimerโ€™s on and insulin

resistance

AB Science masitinib An oral

SA Late-stage study tyrosine kinase

for inhibitor that

mild-to-moderate targets immune

Alzheimerโ€™s cells

responsible for

neuroinflammati

on

Annovis buntanetap An orally

Bio Mid-to-late-stage administered

trial for moderate small molecule

Alzheimer's inhibitor of

several

neurotoxic

proteins

Cognition CT1812 Oral drug

Therapeuti Mid-stage trial designed to

cs for bind to a

mild-to-moderate specific

Alzheimerโ€™s receptor in

brain cells,

which mediates

beta-amyloid

attachment

Coya COYA 301 Designed to

Therapeuti Mid-stage trial inhibit

cs for molecules

mild-to-moderate responsible for

Alzheimerโ€™s neuroinflammati

on and improve

cognitive

function

Actinogen xanamem Blocks the

Medical Mid-stage trial production of

Limited for the stress

mild-to-moderate hormone

Alzheimer's cortisol,

associated with

cognitive

impairment, in

brain cells

AC Immune ACI-24.060 An

SA Early-to-mid-stage antibody-based

trial for immunotherapy

Alzheimerโ€™s vaccine

designed to

target

beta-amyloid

plaque

Biogen BIIB080 An antisense

Mid-stage trial oligonucleotide

for early-stage therapy

Alzheimerโ€™s directed

against "tau"

proteins

Longeveron lomecel-B A cell therapy

Mid-stage trial designed to

for mild stimulate

Alzheimerโ€™s neuroregenerati

on and prevent

the progression

of the disease

(Reporting by Pratik Jain and Mariam Sunny in Bengaluru; Editing by Maju Samuel and Pooja Desai)

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