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FDA fast-tracks AstraZeneca’s Farxiga in heart failure

Races to become first-in-class


AstraZeneca’s Farxiga (dapagliflozin) has scored fast track designation (FTD) from the FDA in the US, continuing its upward trajectory in heart failure.

Earlier this month, AZ revealed the results of the DAPA-HF trial of its diabetes therapy Farxiga, to an eager crowd at the European Society of Cardiology. This study investigated Farxiga in heart failure patients with reduced ejection fraction (HFrEF).

The results were impressive – lead investigator John McMurray of the University of Glasgow said that Farxiga reduced the composite of cardiovascular death or worsening of heart failure by 26% (p<0.0001) when added to standard therapy. This benefit was seen in both diabetic and non-diabetic patients.

AZ is now continuing to count its fortunes with Farxiga, after winning FTD for the development of the therapy in adults with both heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF).

Mene Pangalos

Mene Pangalos, executive vice president, biopharmaceuticals R&D, AZ

“Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis," said Mene Pangalos (pictured above).

"This fast track designation for Farxiga brings us closer to fulfilling our ambition to help prevent, treat and cure heart failure, and we look forward to working with the FDA to explore Farxiga as a potential new treatment option for heart failure patients,” he added.

Farxiga is the first drug in the class to complete a cardiovascular outcomes trial in HFrEF, which could open a new treatment category for these patients.

However, as HFrEF accounts for only around half of all cases of heart failure, researchers are hoping that Farxiga can prove a similar benefit in HFpEF. This hard-to-treat form of the disease currently has no approved drug therapies.

The DELIVER and DETERMINE studies are currently studying Farxiga in HFpEF, which is also studying the therapy in patients with HFrEF. According to AstraZeneca, the FTD was based on the phase 3 trials DELIVER and DAPA-HF.

Farxiga is already growing quickly for AZ, with a possible heart failure claim adding to this momentum by extending its use. It also renews hope for the pharma company that it can chase down SGLT2 market leader Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim.

Like Farxiga, Jardiance received a fast track review status in June, in both HFrEF and HFpEF, with the two separate arms of the EMPEROR trial expected to complete and produce initial results in 2020.

The race to first-in-class for HFpEF is shaping up to be a close one, with each of the contenders hoping to demonstrate the best outcomes.

One of these is Novartis – the Swiss pharma is also looking to add a licence for its therapy Entresto in patients with HFpEF, with read outs from that study expected later this year from its Paragon-HF trial.

Article by
Lucy Parsons

16th September 2019

From: Regulatory



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