Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade
Drugs and vaccines from the pre-clinical phase of development, through phases I, II, and III were evaluated for PRV eligibility (Figure 1). A total of 17 drugs in clinical development could earn a PRV, if approved by the FDA; two more are already approved abroad and would be eligible to earn a voucher if submitted to the FDA (six in phase I; eight in phase II; three in phase III). Forty-five vaccines are currently undergoing clinical development (16 in phase I; 24 in phase II; five in phase III); three additional vaccines are already approved abroad and would be eligible to earn a PRV if submitted to the FDA. The analysis excluded programs that are “on hold”.