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AZ – BMS’ Forxiga receives CHMP recommendation for type 2 diabetes

Step towards EU approval for insulin-independent treatment despite cancer risks

Forxiga, co-developed by AstraZeneca and Bristol-Myers Squibb is the first in a new class of insulin-independent diabetes drug that has been recommended by the European Committee for Medicinal Products for Human Use (CHMP).

The Committee, which advises the European Medicines Agency (EMA), said the drug should be available for use in people with type 2 diabetes as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients.

If approved by the European Commission, it would be the first diabetes treatment available in Europe that works by inhibiting the sodium glucose co transporter 2 (SGLT2), a transporter protein in the kidneys that allows glucose to be reabsorbed into the bloodstream.

This would allow more sugar to be excreted with urine, meaning people with diabetes could improve their control of blood sugar without the need for insulin.

The European recommendation follows a decision in January 2012 from the US Food and Drug Administration (FDA) that declined to approve Forxiga as more clinical data was needed to assess the drug's benefit to risk ratio.

Particular concerns were that the drug has been linked to an increased risk of breast and bladder cancer.

In its recommendation, the CHMP did point out the cancer risks, as well as limited data available in patients above 75 years.

However, the Committee said these risks were 'satisfactorily addressed in the product information and in the risk management plan for Forxiga'.

The CHMP also pointed out that phase III trials involving over 5,600 patients demonstrated the drug improved glycaemic control, with the effect being maintained for two years.

There is an increasing need for additional type 2 diabetes treatments due to the increasing prevalence of the disease, according to the EMA, with data released at 2011's European Association for the Study of Diabetes (EASD) suggesting that the number of people living with diabetes across the world in 2011 has reached 366m.

Big-selling type 2 diabetes treatment Avandia from GlaxoSmithKline (GSK) was also taken off the market in Europe and had its use in the US restricted after it was linked to an increased risk in cardiovascular events.

Other diabetes treatments to face safety concerns include Takeda's investigational treatment alogliptin and Eli Lilly's Actos (pioglitazone), which has been linked to bladder cancer.

23rd April 2012

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