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21 Mar 2017

Case Study : World’s first global “real world” trial : AstraZeneca’s diabetes drug Dapagliflozin

Molecule: Dapagliflozin

Mechanism of Action: Dapagliflozin is part of a new class of drugs that act by removing excess glucose from the kidneys

Brands: marketed inside the US as Farxiga, and outside the US as Forxiga

Diabetes affects around 415m adults globally and is estimated to rise to 642m by 2040, around one in 10 adults.


AstraZeneca’s Dapagliflozin – was the first drug in its class to launch and has more than 40% market share.

Other molecules

  • Canagliflozin by Janssen
  • Empagliflozin, developed jointly by Boehringer Ingelheim and Eli Lilly & Co

Market Planning

  • Astra-Zeneca has weak sales performance due to Crestor, its cholesterol medication and Nexium, a stomach acid treatment, which have recently lost market exclusivity.
  • Overall, the company’s product sales in diabetes rose 11 per cent to $2.4bn in 2016, driven by the performance of Farxiga, sales of which rose 72 per cent year on year to hit $835m.
  • AstraZeneca’s cardio vascular and metabolic diseases division, which includes diabetes, generated more than $8.1bn in revenue, representing 38 per cent of total product sales for AstraZeneca.

So, AstraZeneca PLC is banging big on Farxiga diabetes drug, as company invested hugely on this molecule’s clinical trial, The World’s first global “real world” trial.

World’s first global “real world” trial

  • This trial showed that the rate of hospitalisation for heart failure and death from any cause fell by about half for patients taking drugs in this class.
  • A study of more than 300,000 people spanning six countries
  • The real world trial covered six countries — Denmark, Germany, Norway, Sweden, the UK and the US — and 300,000 people.
  • It found that the rate of hospitalisations for heart-related complications fell 39 per cent among patients taking the newer class of diabetes medication, known as SGLT-2 inhibitors, compared with patients taking other medicines for type 2 diabetes. The risk of death from any cause fell 51 per cent.
  • Around 87 per cent of the study participants, which came from across six countries, did not have a history of cardiovascular disease.
  • The study of more than 300,000 people in six different countries revealed that treatment with Farixga reduced the rate of hospitalisation for heart failure by 39% and death from any cause by 51%, compared to other type-2 diabetes drugs.

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