Multidrug resistant pulmonary tuberculosis

South Africa's Competition Commission has decided not to move ahead with prosecuting allegations of anticompetitive conduct against Johnson & Johnson and its Janssen unit after the company agreed to cut the price of its tuberculosis (TB) drug Sirturo (bedaquiline) by about 40% in the country.The probe, which began last September, examined accusations that Johnson & Johnson had filed a secondary patent for Sirturo, potentially restricting generic competition until 2027 and enabling the company to charge "excessive" prices to South Africa's National Department of Health."The decision to non-refer the complaint of alleged anti-competitive conduct... to the Competition Tribunal for prosecution, follows extensive engagements with the two companies," according to a statement by the Competition Commission. "The companies, in turn, have agreed not to enforce the bedaquiline patent in 134 low- and middle-income countries, including South Africa."After backlash from advocacy groups against the decision to enforce patents on Sirtuto in several markets, the drugmaker confirmed its intention last year to forgo patents in those countries.South Africa's Competition Commission noted that the discounted price aligns with what Johnson & Johnson offers to the Global Drug Facility, the world's largest procurer of TB medicines and diagnostics.The decision coincides with a pair of regulatory milestones for Sirturo. Earlier this month, the drug received full approval in the US and EU for the treatment of multidrug-resistant pulmonary tuberculosis in adults and children aged 5 and older.

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.

Johnson & Johnson on Tuesday said the FDA and the European Commission granted full approval to Sirturo (bedaquiline) as a part of combination therapy to treat multidrug-resistant (MDR) pulmonary tuberculosis (TB) in adults and children aged 5 and above weighing at least 15 kg. Sirtuto secured accelerated clearance from the FDA for use in adults in 2012, with subsequent label expansions to include adolescents in 2019 and children the following year. Meanwhile, conditional approval from the European Medicines Agency (EMA) came through in 2014. Respective applications for the transition to traditional approval were filed with the US and EU regulators in August and November last year, with the EU drug advisory panel adopting a positive stance in April. The conversion to full approval was based on findings from the Phase III STREAM Stage 2 study, which investigated an all-oral Sirturo-based regimen in around 200 patients with MDR-TB, including those with rifampicin-resistant and isoniazid-sensitive infection. Results showed a significant improvement in treatment outcomes with the Sirturo-based regimen versus injectable-containing regimens.Johnson & Johnson noted that when launched, Sirtuto “was the first medicine for TB with a novel mechanism of action to be introduced in over 40 years” and has now positioned itself as “a core component of the World Health Organization-recommended treatment guidelines for drug-resistant TB.” After a backlash from advocacy groups against the decision to enforce patents on Sirtuto in several countries, the drugmaker confirmed last year that it would forgo patents in 134 low- and middle-income countries (LMICs). Around the same time, the company awarded the Stop TB Partnership’s Global Drug Facility (GDF) a license to tender, procure and distribute generic versions of the drug in most of the LMICs.