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Sanofi diabetes drug gets FDA approval

29 Oct 2008

Regulatory Affairs

A diabetes drug developed by Sanofi-aventis has been granted regulatory approval by the US Food and Drug Administration (FDA).

The company said that Apidra has been approved for the treatment of type-one diabetes in children aged four years and over.

Apidra is fast-acting and has a short-lasting effect, which means it is usually used in combination with a longer-acting or basal insulin.

Michelle Baron, vice-president of the metabolism medical unit at Sanofi-aventis in the US, welcomed the FDA's decision.

"Sanofi-aventis is committed to providing children with diabetes, as well as their families and healthcare providers, with safe and effective treatment options to help address the challenges associated with the condition," she remarked.

Meanwhile the firm's vaccines division Sanofi Pasteur has announced that an investigational high-dose influenza vaccine has demonstrated increased immune responses compared to the standard flu jab.

The company was commenting on results from a phase-three study of almost 4,000 people aged 65 and over.


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