FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need

Today, the U.S. Food and Drug Administration announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases. Applicants who submit applications for drug or biological products to prevent or treat these diseases may qualify for a tropical disease priority review voucher (PRV). A tropical disease PRV can be used to obtain priority review of a subsequent drug application that does not itself qualify for priority review.

August 23, 2018

Media Inquiries

  Theresa Eisenman
  301-796-2969

“Part of our work to protect and promote public health of Americans includes monitoring global diseases and pathogens and ensuring we have a robust pipeline of drugs and biologics to treat or prevent the spread of these infectious diseases. Today we’ve 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. 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,” said FDA’s Chief Scientist RADM Denise Hinton. “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. But because these diseases are found primarily in low- and lower-middle income countries, existing incentives have been insufficient to encourage the development of new and innovative drug and biological products. With the tropical disease priority review voucher program, Congress intended to stimulate development of drugs and biologics to prevent and treat infectious diseases for which there are no significant markets in developed nations and that disproportionately affect poor and marginalized populations.”

Today, the U.S. Food and Drug Administration announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases. Applicants who submit applications for drug or biological products to prevent or treat these diseases may qualify for a tropical disease priority review voucher (PRV). A tropical disease PRV can be used to obtain priority review of a subsequent drug application that does not itself qualify for priority review.

To be eligible for a tropical disease PRV, a drug application must meet the criteria in section 524 of the Federal Food, Drug, and Cosmetic Act. The criteria include that the application must be for the prevention or treatment of a “tropical disease.” Beyond the list of “tropical diseases” in the statute, the FDA 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. Interested parties can submit additional disease candidates for designation to a public docket (FDA-2008-N-0567-0011) for the FDA’s consideration.

Products developed to treat or prevent Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis that meet the other criteria for eligibility can now qualify for tropical disease PRVs, hopefully helping to encourage development of safe and effective products for these harmful diseases.

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Author: DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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