AstraZeneca (AZN.L) on Monday won European endorsement for its blockbuster drug, dapagliflozin, as a treatment for all forms of heart failure, the company said.
The drug, which belongs to a class of medicines called SGLT2 inhibitors and is branded as Forxiga in the European Union, raked in about $1 billion in sales in the first three quarters of 2022.
If broader EU approval comes through, it will increase Forxiga’s addressable heart failure patient population by 50%, Ruud Dobber, who leads AstraZeneca’s biopharma business said.
“The current assumption is that the prices we are charging for Forxiga will remain the same also after this new indication,” he added.
Whilst Forxiga remains very important to the company’s current sales, it is not so important to AstraZeneca’s future story given the drug is set to lose patent exclusivity in the next few years, Barclays analyst Emily Field said.
The EU recommendation is based on a pooled analysis of trial data involving about 11,000 heart failure patients that showed the drug reduced the risk of death from cardiovascular causes – including heart attacks – by 14%, and death from any cause by 10%.
Heart failure occurs when the heart muscle becomes unable to pump blood as efficiently as it should, and can cause a range of serious health problems and death.
Seperately on Monday, AstraZeneca said its drug Imfinzi failed the main goal of a late-stage study in patients with a form of late-stage lung cancer.
Imfinzi was tested as a monotherapy against platinum-based chemotherapy in non-small cell lung cancer patients whose tumour cells express high levels of PD-L1, or in a subgroup of patients at low risk of early mortality, AstraZeneca said in a statement.
Imfinzi, which generated $2.41 billion in sales last year, belongs to the immunotherapy class of treatments that boost the body’s own defences to fight cancer by using antibodies that block or bind to foreign substances in the body.
PD-L1 is found on the surface of many cancer cells and impairs the immune system’s ability to fight the disease.
Imfinzi did, however, meet a secondary study goal by helping a subset of patients with PD-L1 tumour expression greater than 50%, live longer.
This latest setback is not necessarily a big deal – investors are far more focused on an ongoing lung cancer trial that pits another AstraZeneca cancer drug, Tagrisso, against a Johnson & Johnson (JNJ.N) therapy, Barclay’s Field said.