60 Degrees Pharmaceuticals (60P) has received Fast Track designation from the Food and Drug Administration (FDA) for the investigation of Tafenoquine for prevention of malaria in adults.
A drug is designated as a fast track product “for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition,”1 according to the FDA.
In December, 60P submitted a New Drug Application (NDA) to the FDA for the use of Tafenoquine to prevent malaria in adults traveling to areas where the disease is prevalent.
Malaria, a life-threatening disease transmitted through the bite of an infected mosquito, caused an estimated 429,000 fatalities and 212 million clinical cases in 2015.2 It poses a significant risk to millions of healthy individuals traveling in many parts of the world, including employees of non-governmental organizations, casual vacationers, industrial and business workers, and military forces.3
Malaria cases among travelers returning to the U.S. have been trending upwards, with 84 percent of those infected requiring hospitalization.4
“Finding acceptable drugs to safeguard travelers and deployed military personnel against malaria is a real problem,” said Geoffrey Dow, Ph.D., CEO 60 Degrees Pharmaceuticals. We see Fast Track Designation as a next step toward marketing this product with a convenient weekly dosing regimen in the United States, and eventually around the world. It is our continued belief our dossier will receive priority review, thereby expediting the review of Tafenoquine.”
60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) in 2014 to develop Tafenoquine as a weekly prophylactic drug for the prevention of malaria.
Since malaria is the top infectious disease threat to U.S. Military service members overseas, the military maintains a robust anti-malarial drug development effort through internal research and commercial partnerships.
A recent analysis of five clinical trials to assess the safety and tolerability of Tafenoquine has been published in Travel Medicine and Infectious Disease, a peer reviewed journal. The authors concluded that Tafenoquine appeared to be safe and well tolerated when the anticipated clinical regimen (ACR) was administered.
In all five studies, the majority of adverse events were mild or considered unrelated to the study drug.
See the full article: “Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis,” by Moreno et al., 2017.
1 Guidance for Industry, Expedited Programs for Serious Conditions-Drugs and Biologics, U.S. Department of Health and Human Services Food and Drug Administration, May 2014, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
2 CDC. 2017. Malaria Facts.
3 WWARN. 2017. Antimalarial Drug Resistance https://www.wwarn.org/about-us/malaria-drug-resistance
4 Cullen KA, Mace KE, Arguin PM. Malaria Surveillance-United States, 2013 MMWR Surveillance Summary 2016:65 (No.SS-2);1-22 DOI: https://dx.doi.org/10.15585/mmwr.SS6502a1
(Source: 60 Degrees Pharmaceuticals)
Filed Under: Drug Discovery