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FDA adds 4 tropical diseases to priority review voucher
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The FDA has announced that companies who submit applications for drug or biological products to prevent or treat Lassa fever, chikungunya virus disease, rabies or cryptococcal meningitis may qualify for a tropical disease priority review voucher.
“Today we have added four diseases to a program designed to encourage development of new drug and biological products to prevent or treat certain tropical diseases affecting millions of people throughout the world, including Lassa fever, which impacted more than 400 people during an outbreak in Nigeria earlier this year, killing over 100 people,” RADM Denise Hinton, the FDA’s Chief Scientist, said in a press release. “Tropical diseases cause a significant health burden globally. Yet there has been remarkably little progress over the past 50 years in drug and biologic development to treat and prevent these diseases.”
Hinton added that “although tropical diseases generally are uncommon in the United States, tourism, immigration and military operations are increasing the direct effect these diseases can have on the health of Americans.”
The agency noted that a tropical disease can be used by a company to obtain priority review of a subsequent drug application that would not itself quality for priority review.
“The FDA priority review voucher (PRV) program has been a critical driver of industry engagement in creating new products for solutions for diseases that are rare in the U.S. but can be devastating globally when they occur,” Regina Rabinovich, MD, MPH, president of the American Society of Tropical Medicine and Hygiene, told Infectious Diseases in Children. “The addition of Lassa fever, chikungunya, rabies and cryptococcal meningitis to the list of eligible diseases is a welcome addition, as it provides an incentive to develop solutions that without this type of program face a significant innovating and development gap.”
A drug application must meet the criteria in section 524 of the Federal Food, Drug, and Cosmetic Act to be eligible for a tropical disease PRV, according to the release. The FDA added that beyond the list of “tropical diseases” in the statute, the agency can issue an order to designate additional diseases as tropical diseases “if the agency determines that a disease has no significant market in developed nations and disproportionately affects poor and marginalized populations.” – by Bruce Thiel
Disclosures: Hinton and Rabinovich report no relevant financial disclosures.