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EMA updates diabetes drug development guide

New long-term safety requirements come into force in November

The European Medicines Agency has updated its decade old guidelines on the development of drugs to treat diabetes with new requirements for long-term safety studies.

The guidelines come into force on November 15, after which companies developing anti-diabetic agents will need to provide new information on cardiovascular safety. 

The decision to update the earlier version came in part on the back of safety concerns with already-marketed diabetes medications, including GlaxoSmithKline's Avandia (rosiglitazone) which was taken off the market in Europe in 2010 and restricted in the US after being linked to increased risk of heart attacks and stroke. 

"In the past, the assessment of cardiovascular safety in the context of the clinical development of glucose lowering agents has not been possible," note the guidelines.

"For future developments, it is expected that the development programme provides sufficient information supporting the lack of a drug-induced excess cardiovascular risk."

Pharma companies will need to collect non-clinical data using "relevant" animal models, as well as clinical data using either a meta-analysis or a long-term controlled outcome study with at least 18 to 24 months of follow-up.

The EMA will also take a more risk-based approach to reviewing new diabetes drugs. For example, if a cardiovascular safety signal emerges in earlier studies then a long-term outcome study will almost certainly be required. Conversely, if other drugs in the same class have no evidence of cardiovascular risk the need for an outcome study is reduced.

More specific and up-to-date information on studies in children will be required, according to the EMA, while the update also includes new sections on the prevention or delay of the onset of type 1 or type 2 diabetes, as well as the preservation of beta-cell function in type 1 diabetics.

A section on complications of diabetes has been removed from the guideline for the time being, "as it still needs substantial revision", according to the agency.

In a nod to the future, the new guideline also includes a section covering other potential claims for diabetes drugs, notably the ability to delay or even prevent the disease in high-risk patients. 

In this case the primary endpoint should be cumulative diabetes incidence or the time to diagnosis of diabetes, it says.

• EMA's Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus

6th July 2012

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