FDA approves new drug for deadly tuberculosis

17 Août, 2019, 10:43 | Auteur: Yves Courtet
  • Peru TB detection

Pretomanid in combination with bedaquiline and linezolid is approved for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB.

But, pretomanid used in combination with bedaquiline and linezolid should not be used in patients with hypersensitivity to bedaquiline or linezolid, the FDA warned.

"As the third new drug developed for TB in over half a century, and the first to be developed as part of a ready-to-use treatment regimen, pretomanid's approval represents another potent tool for tackling difficult-to-treat drug-resistant forms of TB", said Médecins Sans Frontières (MSF), in a statement. "New treatments are important to meet patient national and global health needs".

For the tens of thousands of people around the world who become infected with an extensively drug-resistant form of TB each year, pretomanid "could be a major breakthrough", said Matthew Kavanagh, a health policy expert at Georgetown. This three-drug regimen was studied in a Nix-TB trial across three sites in South Africa in patients with extensively drug-resistant TB, or multi-drug resistant TB. Another, Innocent Makamu, said patients on the standard regimen discouraged him from joining the trial-but within a month, he could tell he would be cured. Treatment for drug-susceptible TB lasts 6 months.

Everitt thinks BPaL will be a significant improvement for patients.

"It's a much shorter treatment, a much simpler treatment, and it will be lower cost simply because it's only three drugs and the healthcare system doesn't have to be treating people for 18 to 24 months", he said. The WHO typically adopts FDA approvals, so the regimen could soon be used worldwide.

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"There isn't a market to sell (a TB drug) to make money so it was imperative that a nonprofit take that on", Boucher said.

Data from the study indicate that 95 of the first 2017 patients experienced successful outcomes after 6 months of treatment with the regimen and 6 months of follow up, exceeding historical success rates for treatment.

"That all has to be managed carefully", Everitt said. T he TB Alliance was formed to come up with better treatments, and i t has been working on the new drug since 2002. The effort has been supported by the US Agency for International Development and the National Institutes of Health, along with private and philanthropic groups.

"We welcome this approval as it shows the real-world impact of United States government investment in finding new cures and vaccines for the world's deadliest diseases", Global Health Technologies Coalition (GHTC) director Jamie Bay Nishi said in a statement.

The LPAD pathway was established by FDA as a tool to encourage further development of antibacterial and antifungal drugs to treat serious, life-threatening infections that affect a limited population of patients with unmet needs.

In the New England Journal of Medicine this month, researchers and infectious disease physicians argued the current model for antibiotic development is broken, especially because the few companies that do develop them end up competing with each other to develop drugs for the same infections.

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