Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) and European Commission (EC) approvals for SIRTURO (bedaquiline) to treat pulmonary tuberculosis (TB).
The FDA granted the approval as part of combination therapy to treat adult and paediatric patients aged five years and above, weighing a minimum of 15kg, with pulmonary TB resistant to rifampicin and isoniazid.
J&J submitted a supplemental New Drug Application to the FDA in August 2023 and a Type II variation to the European Medicines Agency (EMA) in November, to support the transition to standard marketing authorisation.
The latest FDA decision removes the label restrictions imposed during the asset’s accelerated approval in the US in December 2012.
The EC then converted SIRTURO’s conditional marketing authorisation, granted in March 2014, into a standard marketing authorisation.
This development in Europe comes after EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in April 2024.
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The approvals in the US and European Union (EU) are backed by the multi-country, randomised, open-label Phase III STREAM Stage II study.
This trial assessed the efficacy and safety of an all-oral bedaquiline-containing regimen to treat multidrug-resistant TB.
Study results have shown that a bedaquiline-containing regimen significantly improved treatment outcomes versus injectable-containing regimens.
An antimycobacterial medicine, SIRTURO is not recommended for treating latent TB infections, drug-sensitive pulmonary or extra-pulmonary TB, or infections caused by non-tuberculous mycobacteria.
In August 2023, the company reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025.
