Real world data will help AZ’s Farxiga in cardio battle

AstraZeneca has unveiled real-world data showing a new generation of diabetes drugs – including its own Farxiga – cut hospitalisation from heart failure by 39% and death from any cause by 51%.

The real world data showed that three SGLT-2 inhibitors, Farxiga (dapaglifozin), Janssen’s Invokana (canagliflozin), and Boehringer/Lilly’s Jardiance (empagliflozin), collectively halved the risk of all-cause mortality compared with other type 2 diabetes medicines.

Data from the CVD-REAL trial also produced a composite endpoint of hospitalisation for heart failure and death from any cause, a reduction of 46%.

The real world study is a canny way for AZ to catch up with its rivals, Lilly and BI, whose Jardiance recently gained a groundbreaking label change.  Jardiance is the first diabetes drug able to claim CV benefits, since the FDA approved the change late last year.

The CVD-REAL  trial assessed data from more than 300,000 patients across six countries, 87% of whom did not have a history of cardiovascular disease.

Farxiga is one of a group of drugs that AZ hopes will revive its fortunes as sales of its Iressa (gefitinib) for lung cancer and Crestor (rosuvastatin) cholesterol pill fall away because of generic competition.

Sales of Farxiga were up 57% to $239 million in Q4 2016, compared with the same period in 2015, and the company hopes the data will help propel Farxiga past the billion dollar annual sales mark.

When AZ successfully fought off a takeover bid by Pfizer back in 2014, the company said Farxiga could bring in peak sales of $8 billion, as CEO Pascal Soriot set an ambitious sales target of $45 billion by 2023.

The hospitalisations for heart failure analysis was conducted using anonymised patient data from Denmark, Germany, Norway, Sweden, United Kingdom and the United States. Of the data reviewed, 41.8% of patients were on Farxiga, 52.7% on Invokana and 5.5% on Jardiance.

The study therefore boosts the claim of Invokana for cardiovascular protection even more than Farxiga, and supports the notion that this is an effect seen across the SGLT-2 class.

The analysis of death from any cause was conducted using anonymised patient data from Denmark, Norway, Sweden, United Kingdom and the United States. Of the data reviewed, 51.0% of patients were on Farxiga, 42.3% on Invokana and 6.7% were on Jardiance.

However while the data is encouraging, AstraZeneca won’t be able to use it to gain a label extension – it will have to wait for its own DECLARE-TIMI clinical trial outcomes study, which isn’t due to report until 2019.

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