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.

TB Alliance secures Pretomanid FDA approval. Photo courtesy of TB Alliance.

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.

For more pharma regulatory news like Pretomanid FDA approval, keep following Pharma News Daily.

Related posts

• US gene therapy company Renovacor raises $11m for BAG3 gene therapy (0)
• Landos Biopharma secures $60m in Series B financing round (0)
• AtriCure to acquire Californian medical device company SentreHEART (0)
• Neoleukin completes merger with Aquinox Pharmaceuticals (0)
• NKF to invest $95m in US generic injectables company Meitheal (0)
• ORIC Pharmaceuticals raises $55m to advance cancer resistance drugs (0)
• Dynacure’s centronuclear myopathies drug DYN101 gets FDA orphan drug designation (0)
• Windgap Medical, ALK-Abello forge partnership for epinephrine autoinjector (0)
• 89bio begins phase 1b/2a NASH clinical trial of BIO89-100 (0)
• Bayer to fully acquire US cell therapy company BlueRock Therapeutics (0)

The post TB Alliance bags Pretomanid FDA approval for highly drug-resistant TB appeared first on PharmaNewsDaily.com.