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.

 

48. Finalize the development of child-friendly linezolid for the treatment of drug-resistant TB, with an aim of submitting a dossier to WHO PQ and GF ERP by the 3rd quarter of 2021.

49. Finalize the development of child-friendly ethambutol 100mg for the treatment of drug-sensitive and drug-resistant TB, by finalizing any remaining items with GF ERP in Q1-2021.

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 48:

March 2022

  • Linezolid DT 150mg  -  The product dossier was submitted with WHO PQ and assigned reference # TB389.  This is now under active assessment

 

April 2021

  • Micro Labs proposed child-friendly formulation of linezolid is on track for submission according to the commitment timelines

Commitment 49:

March 2022

  • Ethambutol DT 100mg  (TB368) -  Micro Labs have received the committed timely approval from WHO PQTm and is now a prequalified product available for commercial supplies.  ERP approval was as well in place before the PQ approval.

April 2021

  • Micro Labs has finalized the development of child-friendly ethambutol 100mg. The product has been reviewed by GF ERP and is now eligible for procurement.