(Reuters) - AstraZeneca’s diabetes drug Farxiga has become the first in its class to win U.S. approval as a treatment for heart failure, opening up a major new market opportunity outside of the medicine’s established field.
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 here 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.
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