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FDA to review Sanofi’s lixisenatide for diabetes

Follows drug's European approval under brand name Lyxumia earlier this month


Sanofi received more good news regarding the regulatory progress of its diabetes drug lixisenatide, with the drug accepted for review by the US FDA.

The announcement follows European approval for the GLP-1 receptor antagonist earlier this month to achieve glycaemic control in patients with type 2 diabetes already using an oral glucose-lowering medicinal products and/or basal insulin.

The drug, which is given as a single daily injection, is branded as Lyxumia is Europe but Sanofi said its US proprietary name was still under consideration.

Having accepted Sanofi's filing, regulators in the US will now assess lixisenatide for a similar use to that it is approved for in Europe, in the process analysing data from the GetGoal clinical programme.

This programme demonstrated the ability of lixisenatide to reduce a patient's HbA1c levels while also having a beneficial effect on body weight – helping to counter the increase in weight some patients experience when taking insulin.

Lixisenatide also demonstrated a limited risk of hypoglycaemia, potentially providing a major benefit to patients who are unable to up their use of insulin to control glucose levels due to the risk of this side effect.

The medicine is able to achieve these results through its method of simulating GLP-1 - a naturally-occurring peptide hormone that is released following a meal.

This hormone affects the pancreas by suppressing the secretion of glucagon, which raises glucose levels, and stimulating the secretion of insulin, which reduces blood glucose levels.

It also affects brain function to induce satiety, helping to control body weight.

In addition to analysing the GetGoal programme, the FDA intends to review data from the ongoing ELIXA trial, which is investigating the cardiovascular safety of lixisenatide in patients at a high cardiovascular risk.

The heart risk of diabetes treatments has been high on the regulatory agenda in recent years, with GSK's Avandia being taken off the market in Europe and having its use limited in the US due to its cardiovascular effects.

Related worries also prompted the FDA to refuse the approval of two diabetes drugs from Sanofi's big rival Novo Nordisk earlier this month.

The agency said it could not approve Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) without additional proof of the products' safety via a cardiovascular outcomes trial ahead of registration.

19th February 2013

From: Sales



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