July 1, 2010 – Shorter treatment duration with rifapentine expected to bring
significant benefits to patients -
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the European Commission has granted Orphan Drug status for rifapentine for the treatment of tuberculosis (TB). Rifapentine is an antibiotic member of the rifamycin class, with a higher inhibitory activity against Mycobacterium tuberculosis and a longer half-life than rifampin, the cornerstone of current
TB treatment regimen. These combined are expected to improve the drug exposure of patients to the drug and potentially lead to better efficacy.
European Orphan Drug designation is granted to medicines intended for treatment of life-threatening or chronically debilitating pathologies that affect no more than 5 in 10,000 people in the European Community. The European Commission’s decision follows the positive opinion released by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) that a rifapentine-based combination regimen may be of significant clinical benefit for drug-susceptible TB patients by shortening their tuberculosis treatment.
“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, sanofi-aventis. “To avoid as much as possible the emergence of resistant strains, it is of utmost importance to simplify the treatment of non-resistant TB.”
Sanofi-aventis is revisiting the development of rifapentine to be given daily, in combination with standard daily companion drugs, with the objective of significantly shortening the duration of drug-susceptible TB treatment. This should lead to less premature cessations of treatment, and thus to a reduction of
treatment failures, a lesser risk of development of drug-resistance, as well as a reduction of costs, all of which are expected to bring significant benefits to patients and public health systems.
Rifapentine is currently marketed in the United States for the treatment of pulmonary and drugsusceptible TB within a standard 6-month course combination regimen.
http://en.sanofi-aventis.com/binaries/20100701_RIFAPENTINE_en_tcm28-28921.pdf
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