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 The British drugmaker's shares rose to a record high of 8,683 pence
early Wednesday.
The U.S. Food and Drug Administration (FDA) has approved Farxiga to
reduce the risk of cardiovascular death and hospitalisation for
heart failure in certain patients, regardless of their diabetes
status, AstraZeneca said.
The approval was based on positive results from a late-stage trial
in which Farxiga reduced cardiovascular deaths or hospitalisation
from heart failure, compared with placebo.
"We expect especially the cardiologist to embrace this new treatment
option for the non-diabetic patients," AstraZeneca executive Ruud
Dobber told Reuters.
Many diabetes treatments are facing a squeeze in the United States,
the world's most lucrative drugs market, as powerful insurance
companies and pharmacy benefit managers demand a better deal on
prices.
The approval comes just weeks after AstraZeneca said it was testing
Farxiga as a potential treatment for COVID-19 patients with existing
heart and kidney problems.
Diabetes, heart disease and long-term lung problems are the most
common underlying conditions among Americans hospitalized with
COVID-19, a report https://in.reuters.com/article/us-health-coronavirus-usa-study/diabetes-lung-and-heart-disease-common-in-u-s-coronavirus-patients-cdc-idINKBN21I3HM
in March said.
Farxiga, approved as a treatment for type-2 diabetes, is part of the
SGLT2-inhibitor class of anti-diabetic medication that causes the
kidneys to expel blood sugar through urine and has shown promise in
various heart and kidney condition trials.
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The green light from the FDA may blaze a trail for other drugs in the
SGLT2-inhibitor class to expand outside diabetes, such as Eli Lilly and Co and
Boehringer Ingelheim's Jardiance as well as Johnson & Johnson's Invokana.
But being first will be a boost to AstraZeneca's earnings.
Lilly and Boehringer are also testing the benefits of SGLT2 market leader
Jardiance in heart failure patients with or without diabetes but Astra's Dobber
said these programmes were about 6-8 months behind.
Currently, analysts on average expect Farxiga sales of almost $3 billion in
2024, up from $1.54 billion last year. Farxiga is already among AstraZeneca's
top five drugs by sales.
Heart failure is a life-threatening disease in which the heart cannot pump
enough blood, affecting about 64 million people worldwide. Roughly half of them
suffer from a subtype known as reduced ejection fraction that Farxiga was
approved for.
The news is another win for AstraZeneca's cardiovascular business after Farxiga
in March proved to be "overwhelmingly" effective at slowing chronic kidney
disease ahead of the scheduled end of a drug trial. That may potentially open
yet another new area of treatment for the drug.
At 1010 GMT, AstraZeneca shares were up 1.1% at 8,611 pence.
(Reporting by Aakash Jagadeesh Babu in Bengaluru and Ludwig Burger, Editing by
Sherry Jacob-Phillips, Mark Potter and Elaine Hardcastle)
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