New TB treatment, tested in SA, goes before FDA for approval

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A promising new treatment for extensively drug-resistant (XDR) tuberculosis (TB) that was tested in South Africa has been submitted to US regulators, taking its developers a step closer to providing patients with far better odds of defeating the disease, reports Business Day.

XDR-TB is a strain of the disease that is resistant to a wide range of antibiotics, and consequently difficult to treat. Although the outlook for patients in South Africa has improved with the recent introduction of Johnson & Johnson’s Bedaquiline, the cure rate is still only about 60%.

The report says the new treatment includes the novel chemical entity pretomanid, developed by the TB Alliance, with generic linezolid, and Bedaquiline. This “BPaL” regimen cures 89% of patients, according to the interim results of the Nix-TB trial, presented at the Union World Conference on Lung Health in 2018. “It is a watershed treatment,” the principal investigator of the Nix-TB trial, Francesca Conradie, is quoted in the report as saying.

The trial results have been submitted to a peer-review journal and form the basis of an application lodged by the TB Alliance to register pretomanid – named after Pretoria – with the US Food and Drug Administration (FDA). The TB Alliance’s new drug application is for the use of pretomanid, as part of the new BPaL regimen, to treat patients diagnosed with XDR-TB, as well as patients with drug-resistant (DR) TB who are not responding to treatment.

The TB Alliance said the FDA has granted its application priority review, and a decision is expected in the third quarter of 2019.

The BPaL regimen holds “a lot of promise”, said the health department’s deputy director-general of HIV/TB, child and maternal health, Yogan Pillay in the report. “Any new treatment for TB is welcome.” The health department has asked the TB Alliance to consider applying to register pretomanid with South Africa’s medicines regulator, the SA Health Products Regulatory Authority, said Pillay.

Business Day report

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