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S-A's rifapentine granted Orphan Drug status

Sanofi-Aventis' tuberculosis drug, rifapentine, has been granted Orphan Drug status by the European Commission

Sanofi-Aventis' (S-A) tuberculosis (TB) drug, rifapentine, has been granted Orphan Drug status by the European Commission.

Rifapentine had already received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) for offering a significant clinical benefit to TB patients by reducing the length of treatment.

The drug has been shown to offer a higher inhibitory activity against Mycobacterium TB and has a longer half-life than rifampin – the current standard medicine used in the treatment of TB.

As such, improved drug exposure for patients is expected, with the potential of superior efficacy.

Under its Orphan Drug classification, S-A will receive several benefits for the production of rifapentine, including scientific assistance in the product development phase of the drug; financial incentives such as fee reductions; and marketing authorisation, including 10-year marketing exclusivity in the EU.

"Rifapentine is currently one of the most promising drugs for the improvement of patient compliance, which is key to the success of tuberculosis treatment," said Robert Sebbag, vice president, Access to Medicines, S-A. "To avoid as much as possible the emergence of resistant strains, it is of utmost importance to simplify the treatment of non-resistant TB."

Orphan Drug status in Europe is granted to drugs used in the treatment of life threatening or chronically debilitating pathologies that affect no more than 5 in 10,000 people in the European Union. Medicines which, for economic reasons, would be unlikely to be developed without incentives, can also be given orphan drug status.

1st July 2010

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