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HomeStatement on U.S. FDA Approval of Pretomanid as Part of Bedaquiline-Containing “BPaL” Regimen

Statement on U.S. FDA Approval of Pretomanid as Part of Bedaquiline-Containing “BPaL” Regimen

Attributable to Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson

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Johnson & Johnson welcomes the announcement of the accelerated approval by the U.S. Food & Drug Administration (FDA) of pretomanid—a novel medicine developed by the TB Alliance—as part of a combination regimen for the treatment of adults with pulmonary extensively drug-resistant tuberculosis (XDR-TB) or treatment-intolerant or nonresponsive multidrug-resistant (MDR-TB). The regimen—collectively referred to as BPaL—includes Johnson & Johnson’s bedaquiline, along with linezolid.

This announcement marks an important milestone in the fight against drug-resistant TB by providing a simpler, shorter treatment option for patients who have historically faced lengthy treatment regimens. The inclusion of bedaquiline in the BPaL regimen underscores the critical role of our medicine in efforts to modernize TB therapy.

Johnson & Johnson is committed to providing access to bedaquiline to meet the needs of patients in accordance with World Health Organization (WHO) guidelines for the treatment of drug-resistant tuberculosis, as well as national treatment guidelines. To date, we have delivered more than 125,000 courses of bedaquiline to patients in 127 countries, including the 30 countries designated by WHO as having the highest burden of MDR-TB.

Bedaquiline and pretomanid are two of only three new TB therapies to be introduced in the past half a century. Greater innovation will be needed to achieve the global goal of ending the TB pandemic. To this end, Johnson & Johnson is working through its Janssen Pharmaceutical Companies and in partnership with external leading academic and research institutions to develop novel TB treatments and combination regimens, as part of our comprehensive 10-year initiative on TB.

Stoffels Statement  on TB treatment

For more information about our TB efforts, please visit:

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