TB Alliance's pretomanid gains FDA approval as part of three-drug regimen for highly drug-resistant TB

TB Alliance announced that the FDA approved pretomanid as part of a three-drug, six-month, all-oral regimen for the treatment of people with extensively drug-resistant tuberculosis (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive. CEO Mel Spigelman remarked "the…novel regimen will hopefully provide a shorter, more easily manageable and highly efficacious treatment for those in need."

Pretomanid, which was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway), has been authorised for use as part of the BPaL regimen alongside Johnson & Johnson's Sirturo (bedaquiline) and linezolid. TB Alliance noted that the drug, which belongs to a class of compounds known as nitroimidazooxazines, is expected to be available in the US by the end of this year.

In June, an FDA advisory committee voted 14-4 in favour of approval of pretomanid as part of the BPaL regimen. The agency's final decision was supported by results of the Nix-TB trial, which enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. Results from the study showed that a successful outcome was seen in 89% of the first 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up, which significantly exceeded the historical success rates for treatment of XDR-TB.

Meanwhile, adverse reactions reported during the trial included hepatotoxicity, myelosuppression, as well as peripheral and optic neuropathy. Spigelman indicated that TB Alliance is studying whether it can reduce doses or replace linezolid in the regimen as the drug carries significant side effects.

TB Alliance acquired the developmental rights to pretomanid from Chiron in 2002, while the not-for-profit organisation recently granted Mylan rights to manufacture and commercialise the drug as part of the BPaL regimen, as well as for use as part of the BPaMZ regimen in combination with Sirturo, moxifloxacin and pyrazinamide for drug sensitive- and MDR-TB.

While pricing for pretomanid has yet to be disclosed, Spigelman said "it's got to be affordable," as the ultimate aim is to make the BPaL regimen the treatment of choice for all TB patients. Spigelman added that TB Alliance also plans to license the drug to other manufacturers to help make it available to countries with high TB rates.

Pretomanid is also under review by the European Medicines Agency, while TB Alliance has provided data to the World Health Organization for consideration of inclusion in treatment guidelines for highly drug-resistant TB.

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