Forxiga approved in European Union
pharmafile | November 15, 2012 | News story | Sales and Marketing | AstraZeneca, BMS, Forxiga, diabetes
AstraZeneca and Bristol-Myers Squibb’s first-in-class type II diabetes treatment Forxiga has been approved in Europe – a major filip for the manufacturers.
Forxiga (dapagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which which works by inhibiting the SGLT2 – a protein in the kidneys that allows glucose to be reabsorbed into the bloodstream – improving glycaemic control without increasing insulin secretion.
Its major difference is that it works independently of insulin to help remove excess glucose from the body, and the CHMP recommended in April that the once-daily pill should receive marketing authorisation.
Forxiga is indicated as an adjunct to diet and exercise with other glucose-lowering products – including insulin – as well as on its own in metformin-intolerant patients.
But it has been a bumpy road: although its effect has been shown to last up to almost two years, one clinical study from 2011 showed patients taking Forxiga had higher instances of breast and bladder cancer in patients than those on placebo.
An advisory body for the FDA even rejected the drug, throwing its future into doubt – but the US regulator has now asked for more information on the medicine. However, treatments with novel modes of action are useful in this therapy area, where there remains a high level of unmet need.
“Diabetes is a progressive disease that requires a combination of treatment approaches over time,” said BMS chief executive Lamberto Andreotti.
His counterpart at AstraZeneca, Pascal Soriot, said millions of European patients would find Forxiga a ‘significant advancement’.
The CHMP said earlier this year that the companies will have to conduct an epidemiological study, and wanted the firms to look at the cancer risk as part of a planned study, which will also investigate potential cardiovascular risks to patients.
Figures from the World Health Organisation suggest there are around 350 million people with diabetes – including more than 50 million in Europe – with several million a year dying worldwide from the disease.
Adam Hill
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