Factbox: Madrigal's drug wins first US approval for fatty liver disease NASH as rivals circle
14/03/2024 20:09
March 14 (Reuters) - Madrigal Pharmaceuticals' MDGL.O
drug became the first to win regulatory approval to treat a
serious type of fatty liver disease formerly known as
non-alcoholic steatohepatitis (NASH) as the race to tap a
multi-billion dollar market intensifies.
The approval on Thursday follows limited success to develop
a treatment for the disease, which is closely tied to obesity
and is spreading fast.
The following companies are also developing treatments for
NASH, formally known as metabolic dysfunction-associated
steatohepatitis:
Company Drug name / Further Recent updates
developmental plans
stage
Akero Efruxifermin Drug being The drug
Therapeutics (Mid-stage) tested in significantly
AKRO.O two ongoing reduced scarring
late-stage after nearly two
studies and years in the
a separate mid-stage study,
mid-stage data showed in
study March
Altimmune Pemvidutide Mid-stage Drug, in
ALT.O (Mid-stage) trial data December 2022,
for the achieved more
drug than 75%
expected in reduction in
first liver fat
quarter of content,
2025 compared to
placebo in an
early-stage
trial
Boehringer Survodutide Full trial Trial data from
Ingelheim (Mid-stage) data to be February showed
and presented significant
Zealand Pharma in coming improvement in
ZELA.CO months liver
inflammation and
damage without
worsening
fibrosis or
scarring
Eli Lilly Tirzepatide - The drug helped
LLY.N (Mid-stage) up to 74% of
patients achieve
"absence of the
disease" at 52
weeks, compared
to 13% of
patients on
placebo
Ionis ION224 - Trial data
Pharmaceuticals (Mid-stage) published in
Inc IONS.O March showed
significant
improvement in
liver
inflammation and
damage without
worsening
fibrosis or
scarring
Merck & Co Efinopegdutide - Mid-stage trial
MRK.N (Mid-stage) data from June
showed that
efinopegdutide
significantly
reduced liver
fat in patients
compared to
semaglutide
Novo Nordisk Semaglutide Late-stage No data
NOVOb.CO (Late-stage) study
expected to
enroll
about 1,200
patients
Viking VK2809 Additional The drug, in
Therapeutics (Mid-stage) data from May, helped
VKTX.O the study significantly
to be reduce liver fat
presented in patients
in the
first half
of 2024
89bio ETNB.O Pegozafermin Company Began first
(Late-stage) expects to late-stage study
begin for the drug on
second Wednesday, which
late-stage is intended to
trial in support a filing
MASH for accelerated
patients in approval in the
the second U.S.
quarter of
2024
(Reporting by Pratik Jain and Mariam Sunny in Bengaluru;
Editing by Sriraj Kalluvila and Shounak Dasgupta)
((Pratik.Jain@thomsonreuters.com))