(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:
Company Drug or Stage of Mechanism
Therapy development &
indication
Eli Lilly
and Co Kisunla Secured U.S. FDA’s Designed to
target and
standard approval remove toxic
for protein plaque
early Alzheimer’s in the brain
known as
beta-amyloid to
slow down
cognitive
decline
The An
Eisai Co Leqembi first Alzheimer’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
Alzheimer’s on and insulin
resistance
AB Science masitinib An oral
SA Late-stage study tyrosine kinase
for inhibitor that
mild-to-moderate targets immune
Alzheimer’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
Alzheimer’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
Alzheimer’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
Alzheimer’s vaccine
designed to
target
beta-amyloid
plaque
Biogen BIIB080 An antisense
Mid-stage trial oligonucleotide
for early-stage therapy
Alzheimer’s directed
against “tau”
proteins
Longeveron lomecel-B A cell therapy
Mid-stage trial designed to
for mild stimulate
Alzheimer’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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