Aventis makes regulatory submission for rapid-acting analogue insulin glulisine

Published: 25-Jun-2003

The European Medicines Evaluation Agency (EMEA) has accepted the filing by Aventis of a marketing authorization application for insulin glulisine (rDNA origin) injection, a rapid-acting insulin analogue, for the treatment of type 1 and type 2 diabetes mellitus.


The European Medicines Evaluation Agency (EMEA) has accepted the filing by Aventis of a marketing authorization application for insulin glulisine (rDNA origin) injection, a rapid-acting insulin analogue, for the treatment of type 1 and type 2 diabetes mellitus.

The submission of a new drug application for regulatory approval has also been made to the US FDA for insulin glulisine for the treatment of adults with type 1 and type 2 diabetes mellitus.

Insulin glulisine is a recombinant human insulin analogue that has a more rapid onset and a shorter duration of action than human regular insulin. It is designed to be administered by subcutaneous injection shortly before or soon after meals or by continuous subcutaneous pump infusion, and is intended to be used in regimens that include a longer acting insulin or basal insulin analogue, and in some countries, with oral hypoglycaemic agents to control prandial glucose.

'Insulin glulisine is expected to be a strong addition to the Aventis portfolio of diabetes treatment options,' said Frank L. Douglas, executive vice president for drug innovation and approval and a member of the management board at Aventis. 'It is expected to be a therapeutic option that will help people with diabetes achieve better control of this disease.'

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