The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its medication Sirturo (bedaquiline). The product is now approved for the treatment of adolescents aged 12-18 years and weighing ≥30kg with multidrug-resistant pulmonary tuberculosis (MDR-TB), as part of a combination therapy.
Approval Based on Phase II Study Results
The approval is supported by the outcomes of a single-arm, open Phase II study. The study demonstrated that in the subgroup of adolescent patients with MDR-TB who tested positive for baseline culture, a treatment regimen of 400mg once a day for the first two weeks and 200mg three times a week for the following 22 weeks resulted in a culture negative rate of 75.0% at 24 weeks. This rate is consistent with previous adult studies on MDR-TB. Additionally, a real-world retrospective study from China reported a 100% negative conversion rate of sputum smears at weeks 4 and 24 of the medication regimen containing bedaquiline.
Alignment with WHO Guidelines and NRDL Inclusion
The 9 to 11 month oral short course regimen containing bedaquiline, as recommended in the 2022 WHO guidelines for the treatment of drug-resistant tuberculosis, is also deemed applicable to adolescents. Bedaquiline was initially approved to treat adult patients with MDR-TB in China in November 2016 and was included in the National Reimbursement Drug List (NRDL) in 2019.-Fineline Info & Tech
