AstraZeneca’s diabetes drug Farxiga stormed the heart failure market with a world-class approval last year – and in chronic kidney disease it left potential rival Jardiance in the dust.
The FDA approved Farxiga, also known as dapagliflozin, late Friday for the treatment of chronic kidney disease, including in patients without diabetes.
With this CKD approval, Farxiga has cemented its lead over Eli Lilly and Boehringer Ingelheim’s SGLT2 rival Jardiance, which expects no data from its study on kidney disease outcomes until 2022.
Meanwhile, AZ of the drug will – at least in part – compete with Johnson & Johnson’s own SGLT2 challenger Invokana, which is approved for use in diabetic kidney disease but not in non-diabetic kidney disease patients.
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Back in August, when AZ announced detailed results from Dapa-CKD’s pivotal Phase 3 trial, a company executive said the data had the potential to “rewrite” medical textbooks and AZ’s leadership remains full of news about the approval. Mene Pangalos, EPP for Research and Development of Biopharmaceuticals in the UK Pharmaceutical Industry, described Friday’s green light as “the most significant” advance in the treatment of CRF in more than 20 years.
And it’s a huge market: Around 37 million people in the US have kidney disease, AstraZeneca said.
The FDA granted its approval on Friday based on Dapa-CKD. The study enrolled 4,304 patients with stage 2 to 4 kidney disease and high urinary albumin levels.
In this study, Farxiga plus Standard of Treatment reduced the combined risk of worsening kidney function or death from cardiovascular or kidney problems by 39% compared with placebo. The drug also lowered the risk of mortality for some reason by 31%.
Exploratory analysis of AZ’s Declare-Timi 58 study, which looked at the drug’s cardiovascular effects, indicated that Farxiga is likely to work well in patients with less advanced CRF, the company said in a press release.
With the new approval, Farxiga can be used to reduce the risk of kidney dysfunction, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease.
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The green light was to be expected: in early January, the FDA gave Farxiga’s application for CKD a priority review, making a decision for the second quarter.
Farxiga was originally approved for controlling blood sugar in patients with type 2 diabetes and has developed an impressive range over the past year. In early May, the drug received a prime nod to reduce the risk of serious cardiovascular events in heart failure patients, whether or not they have diabetes.
And Farxiga’s sales show how successful it has been in the market. The drug grossed $ 1.96 billion in 2020, a 30% increase in constant currency. It also shows no signs of slowing down. In the first quarter, Farxiga sales increased 50% to $ 625 million.
In contrast, J & J’s Invokana grossed $ 795 million last year, up 8.2% from $ 735 million in 2019. The drug grossed $ 150 million worldwide in the first three months of 2021 US dollars, the company said in its income statement for the first quarter.