Rifapentine is granted Orphan Drug Status by European Commission for Treatment of Tuberculosis
Sanofi-aventis announced 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.
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.
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.
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