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Sanofi vaccine fast-tracked

Sanofi Pasteur has been granted fast-track status by the US Food and Drug Administration for its investigational C. difficile vaccine candidate

Sanofi Pasteur, the vaccines unit of sanofi-aventis (S-A), has been granted fast-track status by the US Food and Drug Administration (FDA) for its investigational Clostridium difficile vaccine candidate. The vaccine, which is in phase II development, is intended to prevent Clostridium difficile infection, which is one of the most common infections acquired in hospitals in North America and Europe.

Sanofi estimates that there are about 500,000 cases of CDI every year in the US, costing the healthcare system more than $3bn annually.  The problem is only likely to worsen, due to the recent emergence of a hyper-virulent strain of C. difficile, according to the company.

The FDA's fast-track programme is designed to speed the development and review of new drugs and vaccines that treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Under the programme, companies can submit portions of the marketing application to the FDA for review as they are completed.

In addition, the sponsor company of a fast-tracked drug or vaccine is eligible for more frequent meetings and written correspondence with the FDA, and the product candidate is generally eligible for an accelerated approval, which is an approval based on surrogate endpoints.

10th November 2010

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