TPP: For treatment of children or adults infected with malaria
New developments in anti-malarial target candidate and product profiles
13 January 2017
Indication
Uncomplicated malaria
Target population
Children and adults; pregnant women in 2-3d trimester
Efficacy
Minimum/Acceptable: Clinical efficacy (ACPR at day 28 or later; per protocol) >95% PCR-corrected, in a per-protocol population; on day 28; non-inferior to standard of care. Preferred/Optimal/Ideal: >95% PCR-corrected, in a per-protocol population, on days 42–63; non-inferior to standard of care.
Safety
Minimum/Acceptable: Few and manageable drug-related SAEs (serious adverse events), or adverse events leading to exclusion from study in phase III. Preferred/Optimal/Ideal: No drug related SAEs; minimal drug-related AEs; no enhanced risk, no risk of hemolysis in subjects with reduced G6PD activity.
Product type
Drug
Status
Active
Safety
Formulation/presentation:: Minimum/Acceptable: Co-formulated tablets or equivalent, with taste-masking (if needed) for pediatrics. Preferred/Optimal/Ideal: Co-formulated tablets for adults. Dispersible or equivalent with taste masking (if needed) for pediatrics. Dose regimen:: Minimum/Acceptable: Oral, two or three doses. Preferred/Optimal/Ideal: Oral, once. Stability and storage:: Minimum/Acceptable: >=2 years. Preferred/Optimal/Ideal: >=5 years.
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