Appendix: selected adaptive development projects
Category |
Product |
Objectives |
Progress to date |
---|---|---|---|
Expansion of clinical use of existing medicines into new indications and populations |
Femara |
Extend label to treatment of epithelial ovarian cancer |
Phase III clinical trial started recruitment in January 2021. |
Entresto |
Conduct a Phase IV clinical trial to assess the efficacy and safety of Entresto in people with heart failure due to chronic Chagas cardiomyopathy |
The study is still recruiting in Argentina, Brazil, Colombia and Mexico, due to the COVID-19 situation. |
|
Hydroxyurea |
Develop pediatric formulation for treatment of sickle cell disease |
The drug was approved in Ghana in September and |
|
Development of new formulations for greater incremental benefit to vulnerable patients |
Coartem |
Develop pediatric formulation for infants <5 kg body weight |
Enrollment for the first cohort is complete and the trial started in 2021 in collaboration with the PAMAfrica consortium, funded by the European & Developing Countries Clinical Trials Partnership. |
Conducting research that enables us to better pursue adaptive development of new medicines |
Tamoxifen |
Conduct a study to understand how Africa-specific CYP2D6 polymorphism – a key enzyme to metabolize a large number of clinically important drugs – potentially affects how the drug metabolizes in the body |
Enrollment is complete and the study is on track. The final study report is planned for release in Q1 2022. |