Emerging Markets Focused J&J’s Sirturo Approval Tied To Expansive Post-Marketing Study Program
This article was originally published in PharmAsia News
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.
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Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.
Important safety questions remain for what could be the first new tuberculosis drug in 40 years, and there was a lack of efficacy in the key subgroup of black patients.