42. Submit the dossier for DTG 10mg scored dispersible tablet in Q1 2020.
Macleods is one of the Generic partners developing DTG 10 mg DT under the collaborative development program with Unitaid / ViiV / CHAI. Macleods has filed the products with FDA and WHO – and have added an additional manufacturing site to the filing to have flexibility in supply. This potentially impacts the approval by 3 months and shifts the PDUFA date to March 16, 2021.
While there is a small potential delay, however this addition tremendously augments supply capacity in order to fulfil the anticipated demand.
Through the innovative public-private partnership between Macleods, ViiV Healthcare, CHAI and Unitaid; Macleods has now filed the dossier for the pediatric Dolutegravir 10 mg scored dispersible tablets to US FDA for review under the PEPFAR program and also with WHO PQ program for review under the WHO-QSM program”.
Pharmaceutical companies, SRAs, WHO Prequalification Programme (PQ) and NRAs commit to:
1. Accelerate the national drug registration process to enable registration of any ARV listed by WHO EOI in around 40 participating countries within 1 year by ensuring that:
FOR PRODUCTS WITH PQ APPROVAL:
Company submits for registration in countries requesting use of the CRP (based on PQ approval) and process completed within around 4-5 months (country decisions within 3 months, plus submission processing time)
FOR PRODUCTS THAT HAVE NOT YET RECEIVED PQ APPROVAL:
Company submits with USFDA for full approval or tentative approval and process completed within 6 months;
USFDA approval or tentative approval review shared with WHO for Collaborative Registration
Procedure-lite (CRP-lite), a pilot program at first allowing FDA to share up to 5 minimally redacted reviews.
Company submits for registration in countries requesting use of the CRP (based on WHO PQ, FDA (CRP-lite) or other SRA review) and process completed in around 4-5 months (country decisions within 3 months, plus submission processing time)
13. Share their methodological approaches to acceptability studies (including palatability and ease of administration) and contribute to a repository held by GAP-f partners to guide future investigation of acceptability for paediatric products.
14. Consider the use of the CRP for national registration of pediatric ARV products on PADO, Optimal formulary and Limited use lists.
15. Ensure all drug registration dossiers meet minimum requirements at the time of filing and that responses to specific queries are complete and provided in a timely manner
20. Manufacture new PADO priority pediatric ARV products “at risk” such that the new product is available for supply at time of approval/tentative approval/prequalification, including validation of manufacturing process during regulatory review.
44. Develop pediatric ARV products at a scale that will meet ultimate market demand as provided by GAP-f partners.
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.
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.