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Review
. 2012;6(10):e1803.
doi: 10.1371/journal.pntd.0001803. Epub 2012 Oct 25.

Analysis of neglected tropical disease drug and vaccine development pipelines to predict issuance of FDA priority review vouchers over the next decade

Rianna Stefanakis  1 , Andrew S Robertson, Elizabeth L Ponder, Melinda Moree
Affiliations
Review

Analysis of neglected tropical disease drug and vaccine development pipelines to predict issuance of FDA priority review vouchers over the next decade

Rianna Stefanakis et al. PLoS Negl Trop Dis. 2012.
No abstract available

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Eligibility decision tree for a US FDA priority review voucher.
Criteria are based on the FDA Draft Guidance for Industry: Tropical Disease Priority Review Vouchers.
Figure 2
Figure 2. Number of PRV-eligible drugs and vaccines in the pipeline by phase of clinical development.
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”.
Figure 3
Figure 3. Estimated approvals of FDA drugs and vaccines for NTDs.
Prediction model used to calculate the total number of expected PRVs, as well as the average annual rate of how many PRVs will be awarded. The model assumes a 100% success rate for approval by FDA of products already approved abroad. (The analysis adjusted for situations where one product approval would deem another ineligible. For example, SM14, a recombinant/purified protein vaccine, is currently under development for both schistosomiasis and fascioliasis. If it were to be approved for schistosomiasis, it would make approval for the indication of use against fascioliasis ineligible. Therefore, SM14 was counted as one product for the purposes of predicting the number of PRVs.) Similarly, the model assumes each individual product in development will yield one product. For malaria vaccines, for example, this may not be the case as many believe that these parts would be combined into one product before licensure. See study limitations for further explanation.
See this image and copyright information in PMC

References

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    1. US Food and Drug Administration (FDA) (2008) FDA draft guidance for industry: tropical disease priority review vouchers. Washington (D.C.): Government Printing Office. October 2008.
    1. Priority Review to Encourage Treatments for Tropical Diseases. Title 21, U.S. Code, Pts. 360n, 2007 ed. Available: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandC.... Accessed 4 January 2012.
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