J&J's TB drug Sirturo gains full EC and FDA approvals

Johnson & Johnson (J&J) has secured approvals from the European Commission (EC) and US Food and Drug Administration (FDA) for its tuberculosis (TB) treatment, Sirturo (bedaquiline). This drug is now fully approved by the EC to treat pulmonary multidrug-resistant tuberculosis (MDR-TB) in both adults and pediatric patients aged five years and older, provided they weigh at least 15kg. The indication for Sirturo is particularly for cases where other drug combinations are not viable due to resistance or side effects. This approval follows a recommendation from the European Medicines Agency’s human medicines committee, which converts the drug’s previous conditional approval from 2014 into a standard marketing authorisation.

Similarly, the FDA has given Sirturo traditional approval for use as part of a combination therapy for adult and pediatric patients aged five years and older, who weigh at least 15kg, and have pulmonary MDR-TB. This new FDA approval removes the label restrictions from the medicine's accelerated approval in 2012, as noted by J&J.

These new authorisations stem from the phase 3 STREAM stage 2 study, which showed that a Sirturo-containing regimen provided significant improvement in treatment outcomes for patients with MDR-TB compared to traditional injectable-containing regimens. According to the World Health Organization, about 410,000 people globally developed multidrug- or rifampicin-resistant TB in 2022. Despite some advancements, the treatment success rate for this form of TB remains alarmingly low.

In addition to the recent approvals for Sirturo, J&J has also seen progress with other treatments. The European Commission has approved Rybrevant (amivantamab) as a first-line treatment for non-small cell lung cancer (NSCLC). This bispecific antibody is authorised for use with carboplatin and pemetrexed chemotherapy to treat advanced NSCLC in adults with epidermal growth factor receptor exon 20 insertion mutations.

Furthermore, J&J's tyrosine kinase inhibitor, Balversa (erdafitinib), has received a positive recommendation from the Committee for Medicinal Products for Human Use. This recommendation is for the treatment of certain adults with unresectable or metastatic urothelial carcinoma.

These approvals mark significant milestones for J&J, underlining the company's commitment to advancing treatment options for serious health conditions like MDR-TB, NSCLC, and urothelial carcinoma.