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The organization has already approached the European Medicines Agency (EMA)A for the official approval of BPaL, (https://www.reuters.com/article/us-tb-alliance-fda/u-s-fda-approves-tb-alliances-treatment-for-drug-resistant-tuberculosis-idUSKCN1V41UU) Reuters A reported Thursday.A
TB Alliance is now targeting adoption and availability of pretomanid as part of the BPaL regimen in countries with a high unmet need for XDR-TB treatments.
Nix-TB data have demonstrated a successful outcome in 95 of the first 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up.
It has been developed as an oral tablet formulation for the treatment of TB in combination with bedaquiline and linezolid, two other anti-TB agents, and is now indicated for use inA a limited and specific population of patients.1A Adverse reactions reported during the Nix-TB trial of the BPaL regimen include hepatotoxicity, myelosuppression, as well as peripheral and optic neuropathy.A Please see additional safety information in the Important Safety Information below and in the accompanying pretomanid Full Prescribing Information.
Initial data from the study shows the promise of BPaL to treat XDR-TB in only 6 months - Bedaquiline (400 mg daily for 2 weeks followed by 200 mg twice a week), Pretomanid (200 mg daily) and Linezolid (1200 mg daily) given orally for 6 months with the option to extend treatment to 9 months for participants who do not culture convert within 4 months.
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- BPA Statement
- BPA Statements
- BPAG 2