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 The British drugmaker said Farxiga was successful in reducing the
risk of deadly heart attacks or disease progression in patients with
a common form of heart failure in a clinical trial that could help
win regulatory approval for its wider use.
Farxiga, already one of AstraZeneca's top 10 drugs by sales, met the
main goal of the so-called DAPA-HF trial, which tested the medicine
in addition to the standard treatment in patients whose heart cannot
pump enough blood.
Farxiga is part of the SGLT2-inhibitor class of antidiabetics that
cause the kidneys to expel blood sugar from the body through urine.
Rival treatments in the diabetes market include Eli Lilly and
Boehringer Ingelheim, but they have yet to show a benefit for heart
failure patients.
Around 40% of participants in the Farxiga trial suffered from type-2
diabetes, as is common among heart failure patients, while the rest
did not.
The results are welcome news for AstraZeneca after U.S. regulators
declined to approved Farxiga for use as a supplement to insulin in
adults with type-1 diabetes where insulin alone was not able to
control blood sugar levels.
Diabetes is associated with a high risk of heart failure.
Heart failure affects about 64 million people worldwide and half of
patients die within five years of diagnosis, AstraZeneca said.
The company, which did not a publish peak sales estimate for the
drug, said trial participants suffered from the HFrEF subtype of
heart failure, accounting for about half of heart failure cases.
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"This (the study results) will give the drug broad applicability and
is strong validation of its utility, particularly in diabetics,"
Liberum analysts said.
"The result will also reinforce Farxiga's utility in diabetes at a
time when oral GLP-1 might enter the market," they added, referring
to a rival group of drugs.
GLP-1 drugs imitate an intestinal hormone that stimulates the
production of insulin. Danish insulin producer Novo Nordisk has
already grabbed a chunk of the diabetes market with its GLP-1 drug
Ozempic.
"The Dapa-HF study was seen as a 'wild-card' by the market, with a
low probability of success, today being the first time a Phase III
study has reported a heart failure benefit for an SGLT-2, in
non-diabetic patients," JP Morgan analysts said.
They added that peak sales potential for the indication could exceed
$900 million.
AstraZeneca shares were up 1.7% at 7,405 pence as of 0948 GMT, the
biggest boost to the UK's blue-chip FTSE 100.
AstraZeneca said it would present more details from the trial at a
later stage and discuss results with drug regulators.
(Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in
Frankfurt; Editing by Patrick Graham and Mark Potter)
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