Johnson & Johnson (JNJ), a global health care company, has received full approval from the US FDA and the European Commission for Sirturo (bedaquiline), a treatment specifically designed for pulmonary tuberculosis resistant to rifampicin and isoniazid.
Sirturo had previously received accelerated approval from the US FDA in December 2012 and conditional approval from the European Medicines Agency (EMA) in March 2014, based on positive Phase 2 study data.
The recent traditional approval by the FDA allows Sirturo to be used as a part of combination therapy in both adults and pediatric patients with pulmonary tuberculosis (TB) caused by mycobacterium tuberculosis strains resistant to rifampicin and isoniazid.
This approval marks a significant milestone, as it removes previous label restrictions.
The decision to grant full approval was based on the Phase 3 STREAM Stage 2 study- a large-scale, randomized, multi-country clinical trial.
The study evaluated the efficacy and safety of an all-oral bedaquiline-containig regimen for multidrug-resistant tuberculosis (MDR-TB). Compared to a 9-month injectable-based regimen, the bedaquiline-containig regimen showed significant improvement in treatment outcomes.
Sirturo is now a core component of WHO-recommended treatment guidelines for MDR-TB with over 845,000 courses shipped to 160 countries.
The company continues to invest in the healthcare professional training, resistance testing, and community-centered initiatives to ensure accessibility and effectiveness of the treatment for TB patients globally.
JNJ has traded in a range of $143.13 to $175.97 in the last 1 year. In the pre-market trading, the stock is at $146.05, up 0.01%
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