Apidra (insulin glulisine) of Aventis, part of the sanofi-aventis Group, has been granted marketing authorization by the European Commission. Apidra is a rapid acting insulin analogue, for the treatment of type 1 and type 2 diabetes mellitus.

Apidra was submitted for registration in the European Union in June 2003. It received a positive opinion from the EMEA on June 3, 2004, which lead to the final commission decision. Apidra was approved by the US FDA in April 2004.

"We are pleased with this European approval and we are looking forward to this important addition to our portfolio of therapeutic solutions for individuals with type 1 and type 2 diabetes. Apidra has demonstrated a consistent profile in a wide range of individuals, including the obese. It also will provide flexibility for individuals needing a rapid acting insulin around their meal." said Ophra Rebiere, vice president, Diabetes, Global Marketing at sanofi-aventis.

In Europe, Apidra is indicated for the treatment of adult patients with diabetes mellitus. It lowers blood glucose (sugar) levels. In combination with Lantus (insulin glargine), a 24-hour, peakless basal insulin also made by Aventis, Apidra provides a synergistic approach to total glucose control for someone with diabetes. Both products will be offered in similar delivery systems making it easier for the patients who need both basal insulin and prandial insulin coverage, release from Aventis says.

Hypoglycemia is the most common adverse effect of insulin therapy, including Apidra. Adverse events sometimes associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus and rash.