July 16, 2018What's New
New York, NY - 5 July 2018: Target Health Inc. would like to congratulate Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) upon U.S. FDA approval of moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. River blindness is caused by a parasitic worm, Onchocerca volvulus. This tropical disease manifests as severe itching, disfiguring skin conditions and visual impairment, including permanent blindness caused by the worm's larvae (microfilariae). The approval of moxidectin was based on data from two randomized, double blind, active controlled clinical studies. Each study met its respective primary endpoints, showing a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in suppressing the presence of the microfilariae in skin.
"MDGH sincerely thanks Target Health, our US Agent and electronic submission contractor for post-NDA submission activities" said Danielle Smith, PhD, Associate Director of MDGH. Dr. Smith added that, "Target's professionalism and expertise ensured that MDGH' s submissions were appropriately presented for approval to the FDA, and Target Health's flexibility was also very much appreciated as there were multiple NDA amendments, many with tight turnaround times. Jules Mitchel,, MBA PhD, President of Target Health added that "Target Health very much looks forward to continuing our successful relationship as MDGH now heads into the post-approval phase." MDGH US Agent and post-submission electronic submission activities at Target Health were managed by Mary Shatzoff, Sr. Director of Regulatory Affairs at Target Health.
The FDA awarded MDGH a priority review voucher (PRV) and full results from the Phase III study were published in the Lancet in January 2018 (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30101-6/fulltext).
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor