TB Alliance’s Pretomanid Combination Therapy Receives the US FDA’s Approval for Highly Drug-Resistant Forms of Tuberculosis

 TB Alliance’s Pretomanid Combination Therapy Receives the US FDA’s Approval for Highly Drug-Resistant Forms of Tuberculosis

TB Alliance’s Pretomanid Combination Therapy Receives the US FDA’s Approval for Highly Drug-Resistant Forms of Tuberculosis

Shots:

  • The approval is based on the Nix-TB trial assessing bedaquiline, pretomanid and linezolid collectively called BPaL regimen in 109 patients with XDR-TB treatment-intolerant or non-responsive MDR-TB across three sites in South Africa
  • The study demonstrated successful outcomes in @6mos. 95/107 patients and for two of the patients the study was extended to nine months. The NDA submission contains data of 1,168 people receiving pretomanid in 19 clinical trials, evaluating its safety and efficacy
  • Pretomanid (PO) is an anti-TB drug in combination with bedaquiline + linezolid, and has received Priority Review, Qualified Infectious Disease Product, and Orphan Drug Designation with expected availability in the end of H2’19. Additionally, the company has also submitted to the EMA

Click here to­ read full press release/ article | Ref: TB Alliance | Image: Pharma News

 

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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