US FDA approves Pretomanid tablets for drug-resistant tuberculosis


The US FDA has approved Pretomanid tablets in combination with bedaquiline and linezolid for the treatment of specific types of drug-resistant pulmonary tuberculosis (TB).

This approval marks the second time a drug has been approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs pathway, which was advanced by the US Congress to spur drug development for infections that lack effective therapies. The pathway allows for smaller, shorter or fewer clinical trials.

Pretomanid has been approved in combination for the treatment of adults with extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant pulmonary TB. These makes up an estimates 490,000 new cases of TB globally each year.

Pretomanid, taken orally in combination with bedaquiline and linezolid, was proved to be safe and efficacious in a clinical trial involving 109 patients with treatment-resistant TB. Out of the 107 patients who were followed up for 6 months following the end of treatment, 89% were successfully treated for TB. This percentage exceeds historical success rates for extensively drug-resistant TB, the FDA thus granted Pretomanid approval under Priority Review.

However, adverse reactions to Pretomanid were noted, including: visual impairment, diarrhea, peripheral neuropathy, anemia, nausea, acne and headaches.

FDA Principal Deputy Commissioner Amy Abernethy, concluded: “New treatments [for TB]are important to meet patient national and global health needs. That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections.”

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What is extensively drug-resistant tuberculosis?

Extensively drug-resistant tuberculosis refers to strains that are resistant to rifampicin and isoniazid (thus multidrug-resistant) and are also resistant to any of the fluoroquinolones and to at least one of the three injectable, second-line drugs (capreomycin, kanamycin and amikacin).

What is Pretomanid?

Pretomanid is a nitroimidazole, a class of antimicrobial compounds that are based on the 5-nitroimidazole organic compound. Nitroimidazole drugs are prodrugs that are activated by reduction of their nitro group to produce cytotoxic intermediates. These intermediates damage DNA and other macromolecules, leading to cell death.


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