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.

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 drug-susceptible TB within a standard 6-month course combination regimen.

Rifapentine is now listed in the Community Register of Orphan Medicinal Products for Human use under the code EU/3/10/750.

Rifapentine is a member of the rifamycin class of antibiotics. Rifampin (rifampicin), the lead rifamycin antibiotic, is the cornerstone of the current 6-month combination treatment regimen for drug-susceptible TB as recommended by the World Health Organization (WHO). Rifapentine is a rifamycin derivative with a higher inhibitory activity against M. tuberculosis and a longer half-life than rifampin. These properties are expected to improve drug exposure and potentially lead to a better efficacy. In an experimental model of TB, replacing rifampin by rifapentine in the standard combination of drugs, reduces from 6 months to 10-12 weeks the treatment duration required to achieve stable cure (Rosenthal et al. Am J Respir Crit Care Med, 2008; 178: 969).

Rifapentine is currently approved in the United States under the trademark Priftin for the treatment of pulmonary drug-susceptible TB in combination with other anti-TB drugs. It should be administered twice-a-week in the Intensive Phase (2 months) and once-a-week in the Continuation Phase (4 months), in combination with daily companion drugs within a standard, 6-month treatment duration.

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. Sanofi-aventis is a producer of rifapentine. Sanofi-aventis was also the very first company to manufacture rifampicin and remains one of the main producers of this fundamental ingredient in all antituberculosis treatments.

The sanofi-aventis “Access to Medicines” department brings together the Group’s areas of expertise to address the challenge of access to healthcare in developing and emerging countries for specific diseases. Sanofi-aventis has a long-standing presence in the TB field: it was the first, and remains a leading producer of rifampin, a mainstay of TB treatment. Sanofi-aventis produces a complete range of anti-tuberculosis medicines distributed in many countries. In addition, sanofi-aventis has set up a Research and Development program for new TB drugs with a specific focus on multi-drug resistant TB.