AstraZeneca diabetes drug recommended in Europe
pharmafile | April 23, 2012 | News story | Sales and Marketing | AstraZeneca, CHMP, FDA, Merck, WHO, diabetes
AstraZeneca and Bristol-Myers Squibb’s new type II diabetes treatment Forxiga has received a positive opinion by European regulators.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending that Forxiga (dapagliflozin) should receive marketing authorisation as a monotherapy, and in combination with other drugs.
This comes depsite poor clinical trial results for the drug, with one study from last year showing patients taking Forxiga had higher instances of breast and bladder cancer in patients than those on placebo.
This led to an advisory body for the FDA to reject the drug, throwing its future into doubt – the US regulator has now asked for more information on the medicine.
But the CHMP’s decision – which should be ratified by the European Commission within three months – has given some reprieve for Forxiga.
The CHMP said it was swayed by the efficacy of the drug, which demonstrated that Forxiga’s effect on improving glycaemic control lasted up to almost two years.
But it said that AstraZeneca and Bristol-Myers Squibb will have to conduct an epidemiological study, and wants the firms to look at the cancer risk as part of a planned study, which will also investigate potential cardiovascular risks to patients.
But overall, the CHMP believes that the manufacturers’ product information and risk management plan are up to scratch.
Forxiga is a once-daily pill 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.
This is the first positive recommended for the first in a new class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors.
Although it works independently of insulin, Forxiga would be used as an adjunct to diet and exercise with other glucose-lowering products including insulin, the CHMP says, as well as on its own in metformin-intolerant patients.
“We are pleased the CHMP has given a positive assessment of the benefit/risk profile,” says AstraZeneca chief executive David Brennan.
As the effects of the drug are dependent on kidney function, it is not recommended in patients with moderate to severe kidney impairment.
In this therapy area, Merck’s oral Januvia franchise had $4.9 billion sales last year while Novo Nordisk’s newer, injectable Victoza has been growing strongly, with $1 billion of sales in 2011.
Figures from the World Health Organisation suggest there were 346 million people worldwide with diabetes as of last August.
In 2004 an estimated 3.4 million people died from the disease, a rate which WHO predicts will double by 2030.
Adam Hill
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