Moxidectin Approved to Treat River Blindness
June 13, 2018 – The U.S. FDA has approved moxidectin to treat river blindness (onchocerciasis) in patients age 12 years and up. The product is manufactured by Medicines Development for Global Health (MDGH), a non-profit, independent biopharmaceutical company that uses all proceeds earned in excess of its operating costs to fund the development of drugs and vaccines for unmet medical needs.
River blindness occurs as the result of a parasitic infection caused by Onchocerca volvulus, a type of roundworm, and is the second leading cause of blindness worldwide. The World Health Organization has classified river blindness as one of twenty neglected tropical diseases (NTDs) in low-income developing regions. NTDs receive comparatively little attention in terms of research and funding when compared to other conditions, such as malaria, tuberculosis, and HIV/AIDS.
In clinical studies, moxidectin demonstrated superior results compared to ivermectin, the current standard of treatment for river blindness. The Global Health Investment Fund (GHIF) and the World Health Organization Special Programme for Research and Training in Tropical Diseases (TDR) contributed to the product’s development.
MGDH also credits the FDA’s new tropical disease Priority Review Voucher (PRV) program for making the development and approval of moxidectin possible. The program is designed to provide incentives for the development of biologics and medications that prevent and treat NTDs. Such products often have little commercial value, which can make it difficult for researchers and manufacturers to obtain funding.
Recommended dosing with moxidectin is 8mg (four 2mg tablets) per day, taken with or without food. MDGH has announced that it will continue to work toward making moxidectin available to populations in need, and pursue further data on the drug’s potential application in treating younger children.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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