Johnson & Johnson secures FDA and EC nods for TB drug

Johnson & Johnson (J&J) has secured approvals from the US Food and Drug Administration (FDA) and the European Commission (EC) for SIRTURO (bedaquiline), a treatment designed for pulmonary tuberculosis (TB). The medication is intended for both adult and pediatric patients aged five and older, who weigh at least 15kg, and who have pulmonary TB that is resistant to rifampicin and isoniazid.

In August 2023, J&J submitted a supplemental New Drug Application to the FDA, aiming to transition SIRTURO to standard marketing authorization. Similarly, in November, the company filed a Type II variation to the European Medicines Agency (EMA) for the same purpose. These submissions followed the initial accelerated approval granted by the FDA in December 2012 and the conditional marketing authorization provided by the EC in March 2014. The latest FDA approval eliminates the label restrictions that were initially imposed during the accelerated approval phase. Concurrently, the EC has converted SIRTURO’s conditional marketing authorization to a standard one.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding SIRTURO in April 2024, paving the way for the EC’s standard marketing authorization. These approvals are supported by the findings of the Phase III STREAM Stage II study, an international, randomised, open-label trial. This study demonstrated that an oral regimen containing bedaquiline significantly improved treatment outcomes for patients with multidrug-resistant TB compared to those treated with injectable-containing regimens.

SIRTURO is an antimycobacterial medication but is not recommended for treating latent TB infections, drug-sensitive pulmonary or extra-pulmonary TB, or infections caused by non-tuberculous mycobacteria. 

In a separate development in August 2023, J&J resolved a legal dispute with Formycon and Fresenius regarding the Stelara biosimilar FYB202, which is set to launch in the US on April 15, 2025.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!