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Pretomanid could potentially be included in WHO guidelines for treating highly-resistant TB, says GlobalData

TB Alliance’s pretomanid was recently approved by the FDA in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. GlobalData, a leading data and analytics company, expects pretomanid to be set in the World Health Organization (WHO) guidelines for individuals with extensively drug-resistant TB (XDR-TB) or multi-drug resistant TB (MDR-TB).

The approval was based on results from 19 clinical trials that showed when Pretomanid was used in combination with the antibiotics bedaquiline and linezolid, 89% of 107 patients with extensively drug-resistant TB were cured after six months.

Arafa Salam, Pharma Analyst at GlobalData, commented: “The drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) pathway as part of a three-drug, six-month, oral regimen for XDR-TB and MDR-TB. The LPAD pathway was established by the FDA in an attempt to encourage further development of antibacterial and antifungal drugs to treat serious, life-threatening infectious diseases that affect a limited population of patients.”

Due to pretomanid’s approval, GlobalData believes there is strong rationale for the drug to be included in the WHO guidelines for treating highly-resistant TB in countries where TB is prevalent, such as India, South Africa, and China, as well as countries where TB is less prevalent but still significant, such as Brazil and Russia.

Salam adds: “Additional TB treatments are desperately needed, as TB has now surpassed acquired immune deficiency syndrome (AIDS) as the world’s leading infection-associated cause of death. Moreover, the WHO has stated that TB is responsible for one out of every three human immunodeficiency virus (HIV) deaths. Therefore, treating TB with pretomanid could impact patients co-infected with other pathogens.”

Pretomanid is expected to be available in the US by the end of 2019. TB Alliance has also submitted pretomanid to the European Medicines Agency (EMA) as part of the bedaquiline, pretomanid, and linezolid (BPaL) regimen.

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  • Company:
    • TB Alliance
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    • TB Alliance
Last Updated: 23-Aug-2019