The Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest for Product Evaluation to the WHO Prequalification Unit was recently updated following a request by the WHO Global Tuberculosis Programme. The updated list can be found here
In particular, a few modifications were included, to streamline WHO’s messages around the formulations of Rifapentine for children and adults to be prioritized for development:
- As agreed by the Paediatric Antituberculosis Drug Optimization (PADO-TB) group - a forum convened by WHO for clinicians, researchers, donors, and other stakeholders - a 150 mg scored dispersible tablet formulation of Rifapentine should be prioritized for development given that it can serve multiple indications and can allow dosing across age groups. The FDC “Isoniazid 150 mg/Rifapentine 150 mg, tablets, preferably dispersible” does not offer this flexibility and was thus removed from the EOI.
- Rifapentine formulations for adults prioritized for WHO Prequalification are:
- Rifapentine, tablet 300 mg (scored)
- Isoniazid 300 mg/Rifapentine, tablet 300 mg (scored)
Given the separate request for a standalone child-friendly formulation of Rifapentine, the need to develop dispersible tablets of the above-mentioned formulations to accommodate both adults and paediatric needs is no longer relevant. Thus, the request to develop "preferably dispersible" tablets was removed from the specific formulations listed in the PQ EOI.
A child-friendly formulation of Bedaquiline (20 mg scored dispersible tablets), was also added to the PQ EOI list, which is a step forward in improving treatment options for children with multidrug- resistant TB.