Aventis announced that the European Medicines Evaluation Agency (EMEA) has accepted the filing 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.
Aventis also announced the submission of a new drug application for regulatory approval to the U.S. Food and Drug Administration (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. Insulin glulisine is designed to be injected shortly before or soon after meals. It 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. It is intended to be given by subcutaneous injection or by continuous subcutaneous pump infusion.
“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. “Aventis has a long and distinguished history as an innovator in the development of insulins, and insulin glulisine is expected to be a therapeutic option that underscores our commitment to offer products that will help people with diabetes achieve better control of this disease.”
Diabetes is a chronic, widespread condition where the body does not produce, or properly use insulin, the hormone needed to convert glucose (sugar) into energy. People with diabetes may need different types of insulin at certain times of the day and at different stages of the progression of their diabetes to help them manage their glucose intake from food. Rapid-acting insulins can be taken shortly before or after a meal to control the peaks in blood glucose levels that happen immediately after eating.