FDA Converts Tuberculosis Treatment Sirturo to Traditional Approval
On June 21, 2024, the FDA converted Sirturo (bedaquiline) from accelerated approval to traditional approval following a determination that a confirmatory trial verified clinical benefit.
Sirturo is indicated for pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid, also known as multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy, for adults and pediatric patients (5 years and older, weighing at least 15 kg).
The National TB Surveillance System reported an increase in TB cases in the United States since 2020, including a 16% increase in overall cases in 2023 compared to 2022. MDR-TB typically makes up less than 2% of diagnosed TB cases in the U.S.
Sirturo was first approved in December 2012 under FDA’s Accelerated Approval pathway. As part of the initial approval, FDA required the applicant to conduct a confirmatory clinical study and develop a patient registry to assess rates of serious adverse events.
More information about Sirturo, including information on warnings and precautions, dosing, and adverse reactions can be found in the FDA-approved prescribing information.
Source: FDA
Posted: June 2024
Related articles
- FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis - May 27, 2020
- Janssen Announces U.S. FDA Accelerated Approval for Sirturo (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis - August 9, 2019
- FDA Grants Accelerated Approval for Sirturo to Treat Multi-Drug Resistant Tuberculosis - December 31, 2012
- U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment - September 5, 2012
- Janssen Research & Development Submits New Drug Application to FDA for Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline (TMC207) - July 2, 2012
Sirturo (bedaquiline) FDA Approval History
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