Pretomanid FDA approval : Non-profit organization TB Alliance has secured approval for Pretomanid Tablets in combination with bedaquiline and linezolid from the US Food & Drug Administration (FDA) for the treatment of highly drug-resistant forms of tuberculosis.
The combination regimen was approved by the FDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) as part of a three-drug, six-month, all-oral regimen for the treatment of extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) in people who are intolerant to treatment or non-responsive (collectively designated as highly drug-resistant TB).
Established by FDA, The LPAD pathway is a tool to encourage further development of antibacterial and antifungal medicines for the treatment of serious, life-threatening infections affecting a limited population of patients with unmet needs.
Commenting on Pretomanid FDA approval, Mel Spigelman – president and CEO of TB Alliance, said: “FDA approval of this treatment represents a victory for the people suffering from these highly drug-resistant forms of the world’s deadliest infectious disease.
“The associated novel regimen will hopefully provide a shorter, more easily manageable and highly efficacious treatment for those in need.”
Collectively called the BPaL regimen, the three-drug regimen made up of bedaquiline, pretomanid and linezolid was evaluated in the Nix-TB clinical trial in three sites in South Africa. The clinical trial, which paved way for the Pretomanid FDA approval, enrolled 109 patients with XDR-TB and also treatment-intolerant or non-responsive MDR-TB.
Nix-TB data had shown a successful outcome in 95 of the first 107 patients following six months of treatment with BPaL and six months of post-treatment follow-up.
Dr. Francesca Conradie, principal investigator of the Nix-TB trial, commenting on Pretomanid FDA approval, said: “Until very recently, people infected with highly drug-resistant TB had poor treatment options and a poor prognosis.
“This new regimen provides hope with 9 out of 10 patients achieving culture negative status at 6 months post-treatment with this short, all-oral regimen.”
Pretomanid is set to be launched in the US by the end of this year.
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