Tuberculosis – shorter, simpler treatments …

[9 July 2010 - 15h26]
[mis à jour le 9 July 2010 à 16h01]

The European Commission has just agreed the status of the orphan drug rifapentin. This antibiotic, specific to Mycobacterium tuberculosis, the bacterium responsible for tuberculosis, could bring significant clinical benefits: implementation of simplified treatment, improved observance, reduction in therapeutic and logistical costs, etc. All of which are potentially determining factors in the prevention of resistant forms of the disease.

Rifapentin is part of the rifamycin group of antibiotics. It therefore belongs to the same group as rifampicin, the reference drug for the treatment of non-resistant forms of tuberculosis. However, according to its developer, the French company Sanofi Aventis, it differs in offering “a stronger inhibition potential for Mycobacterium tuberculosis, and by having a longer half-life than rifampicin”.

Marketed in the United States for the treatment of non-resistant forms of pulmonary tuberculosis, rifapentin is used there as part of a 6-month staggered treatment therapeutic protocol, like rifampicin. However, “in an experimental tuberculosis model, by substituting rifampicin with rifapentin in the standard combination it was possible to reduce the duration (of treatment) needed for a cure from 6 months to 10-12 weeks”, Sanofi Aventis points out.

Reducing the economic impact of treatment This is most certainly where the challenge lies. “It is of the greatest importance to simplify the treatment of non-resistant tuberculosis”, explains Robert Sebbag, the French company’s ‘Access to medicine’ vice-president. The company “has undertaken to redevelop rifapentin as a daily dose, in combination with other standard anti-tuberculosis drugs taken daily, with the aim of significantly reducing duration of treatment (…). This should make it possible to cut down on the number of premature stoppages of treatment and hence (…) the number of treatment failures and also to reduce the risk of development of resistance as well as the global cost” of treatment.

No figures have yet been given for the savings this might be expected to produce. It seems certain that rifapentin will benefit from the differentiated price policy on which the manufacturer’s “Access to Medication” operations are based. According to Philippe Farabolini, the director of pandemic diseases – tuberculosis and malaria – at Sanofi Aventis, “the cost of a 4-month course of treatment with rifapentin should be no higher than that of a 6-month course of treatment with rifampicin. But the improved observance of treatment one might expect and, most importantly, the reduced logistical costs of monitoring patients should constitute appreciable sources of savings”.

The status of orphan drug will facilitate this development. It has been granted under the framework of serious diseases giving rise to vital prognosis and/or chronic disability, which affect fewer than 5 people in 10,000 in the European Community – France, for example recorded fewer than 5,800 cases in 2008 – and against which there is no equivalent treatment in Europe. It affords the developer a number of advantages aimed at compensating for the limited “market” appeal it will have. These include aid with the elaboration of development protocols, centralised procedure and reduced registration costs and 10-year exclusivity on marketing rights in Europe.

It also makes it possible to develop exportable drug models on attractive terms for the countries where they are needed most. Worldwide, in fact, there are around 2 billion M. tuberculosis carriers. Approximately 9.8 million new TB sufferers are diagnosed each year and tuberculosis is responsible for 1.7 million deaths per year … the majority occurring in the more disadvantaged countries of the world.

To find out more:

2009 Update Tuberculosis Facts, OMS

Agence européenne du Médicament (EMEA) : Les médicaments orphelins [European Medicines Agency (EMEA): Orphan drugs]

Source : EMEA, 21 June 2010 - Sanofi Aventis, interview with Philippe Farabolini, 7 July 2010 - DWS Pill Scribe, 6 July 2010

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