SIRTURO (bedaquiline) - Adult and paediatric patients (5 years to less than 18 years of age) with pulmonary tuberculosis (TB)

The clinical benefit of SIRTURO (bedaquiline) is substantial as part of an appropriate combination regimen in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid, at the dosage and in the indications of the MA, and in accordance with WHO recommendations.

Considering:

• the substantial medical need in multidrug-resistant tuberculosis,
• evidence, in the STREAM Stage 2 trial, of the non-inferiority of a short treatment regimen containing bedaquiline compared to another short regimen without bedaquiline with medicinal products administered by injection (difference between favourable response to treatment at week 76 of -11.0% [-19.0%; -2.9%]; p < 0.001), which confirms previous findings and has led to the removal of the marketing authorisation conditions for the treatment of multidrug-resistant tuberculosis,
• demonstration within cohort 2 of the TCM207-C211 pharmacokinetic study that it is possible to use bedaquiline for the treatment of multidrug-resistant tuberculosis in children aged from 5 years to less than 12 years,
• the results of clinical trials and real-world data (with a long-follow-up period) consistently demonstrating higher success rates than those of traditional regimens, with a marked reduction in relapses and mortality,
• the fact that bedaquiline is one of the reference treatment options in adults and children in accordance with the updated WHO guidelines,

the Committee deems that SIRTURO (bedaquiline), in combination with other antibiotics, provides a moderate clinical added value (CAV III) in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with multidrug-resistant tuberculosis.