Johnson & Johnson (J&J) has received approvals from both the European Commission (EC) and US Food and Drug Administration (FDA) for its tuberculosis (TB) treatment, Sirturo (bedaquiline).
The EC has granted the drug full approval to treat pulmonary multidrug-resistant tuberculosis (MDR-TB) as part of an appropriate combination regimen in adult and paediatric patients aged five years and older and weighing at least 15kg.
The EU regulator’s decision, which specifically indicates Sirturo when other combinations cannot be used because the disease is resistant to them or because of their side effects, follows a recent recommendation from the European Medicines Agency’s human medicines committee and converts its previous 2014 conditional approval of the drug to a standard marketing authorisation.
The FDA has also granted Sirturo traditional approval for use as part of a combination therapy for adult and paediatric patients, also aged five years and older and weighing at least 15kg, with pulmonary MDR-TB. The approval removes the label restrictions that were included when the medicine was granted accelerated approval in the US in 2012, J&J outlined.
The new authorisations were based on results from the phase 3 STREAM stage 2 study, in which a Sirturo-containing regimen offered a significant improvement in treatment outcomes for patients with MDR-TB compared to injectable-containing regimens.
An estimated 410,000 people globally developed multidrug- or rifampicin-resistant TB in 2022, according to the World Health Organization, which also noted that the treatment success rate for patients diagnosed with this form of the infection remains “alarmingly low” despite improvements.
The decisions on Sirturo come just days after J&J’s Rybrevant (amivantamab) was approved by the EC as a first-line treatment for non-small cell lung cancer (NSCLC).
The bispecific antibody was specifically authorised for use alongside carboplatin and pemetrexed chemotherapy to treat advanced NSCLC in adults with epidermal growth factor receptor exon 20 insertion mutations.
The company also recently received a recommendation from the Committee for Medicinal Products for Human Use for the use of its tyrosine kinase inhibitor Balversa (erdafitinib) in certain adults with unresectable or metastatic urothelial carcinoma.