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Emerging Markets Focused J&J’s Sirturo Approval Tied To Expansive Post-Marketing Study Program

The first drug approved for multi-drug resistant tuberculosis, Sirturo obtained accelerated approval based on data from two Phase II studies, but has a troubling safety database, including 10 deaths in the treatment arm of its Phase II program.

Johnson & Johnson obtained accelerated approval from U.S. FDA for Sirturo (bedaquiline), a diarylquinolone antimycobacterial drug for multi-drug resistant tuberculosis (MDR-TB), but with a small U.S. patient population and a heavy burden for post-marketing studies, it remains to be seen whether the drug will be a significant profit maker for the pharma.

Bedaquiline also is filed for approval with regulatory authorities in Europe, China and South Africa, with those markets offering larger MDR-TB patient populations.

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