2020 TB TREATMENT

20. Prioritize the development and commercialization of products on the Global Fund Expert Review Panel (ERP) Expression of Interest (EOI) and the WHO PQ EOI.

21. Develop paediatric formulations in line with the PADO TB, GF ERP EOI and the WHO PQ EOI lists, including:

  • Rifapentine 150mg scored dispersible tablet by 2021

  • Linezolid 150mg dispersible tablet by 2021

  • A second supplier of rifampicin/isoniazid/pyrazinamide 75/50/150mg FDC dispersible tablet

  • A second supplier of isoniazid 100mg dispersible tablet

  • A second supplier of ethambutol 100mg dispersible tablet.

50. Finalize the development of 3-medicine pediatric fixed-dose combination product for treatment of drug-sensitive TB, with an aim of submitting dossier to PQ and ERP by July/August 2021.

96. Manufacture paediatric products at a scale that aligns with market demand as provided by GDF.

97. Ensure new products are available for supply at time of approval or prequalification, including validation of manufacturing process during regulatory review.

Updates

Commitment 50:

April 2021

  • Lupin is finalizing the development of the 3-medicine paediatric fixed-dose combination product.

  • Lupin has initiated the development of child-friendly formulations of isoniazid 100mg, ethambutol 100mg and bedaquiline 20mg.