AstraZeneca has started 2020 strongly, with the FDA granting a fast review for its big-selling Farxiga in heart failure and a key drug approval in China.
AZ said the FDA has accepted a filing for Farxiga (dapagliflozin) to reduce risk of cardiovascular death or worsening of heart failure in adults with reduced ejection fraction, with and without type 2 diabetes.
This allows for a faster six-month review of the trial data in the new indication for Farxiga instead of the standard 10-month period.
The filing is based on results from the phase 3 DAPA-HF trial, announced last year, which showed Farxiga on top of standard of care reduced the incidence of the composite outcome of cardiovascular death or worsening of heart failure versus placebo.
Farxiga was first established as a drug controlling blood sugar in patients with type 2 diabetes, but AZ has been working on extending its remit and building sales.
Originally brought into the company after AZ bought out Bristol-Myers Squibb’s share of a diabetes alliance, Farxiga is one of AZ’s most important drugs with revenues north of $1.1m in Q3 alone.
The FDA already approved it in October to reduce chances of hospitalisation for heart failure in adults with type 2 diabetes and other cardiovascular risks.
Lokelma approved in China for hyperkalaemia
In a separate announcement AZ said its Lokelma (sodium zirconium cyclosilicate) has been approved by regulators in China for adults with hyperkalaemia – elevated levels of potassium in the blood.
Approval by China’s National Medical Products Administration (NMPA) was based on positive results from the clinical trials of Lokelma and a pharmacodynamic study in China.
Results showed that patients receiving Lokelma experienced a significant, rapid and sustained reduction of potassium in the blood.
Lokelma was only recently launched in the US and sales have yet to take off, but AZ has high hopes for the drug after acquiring its original developer ZS Pharma for $2.7 billion in 2015.
The news follows the Queen’s decision to award R&D guru Mene Pangalos with a knighthood in the New Year Honours List, an indication of the company’s growing reputation as a scientific powerhouse.
Pangalos has overall responsibility for AstraZeneca’s research and development (R&D) activities in BioPharmaceuticals.
Since joining in 2010, he has pioneered programmes to promote novel open innovation partnerships with non-governmental and peer organisations, and more than 200 academic institutions to help drive the UK’s position as a world leader in life sciences R&D.
