FDA Approves River blindness drug
After a priority review FDA approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older.
The approval of moxidectin was based on data from two randomized, double blind, active controlled clinical studies “FDA approval is a momentous achievement for any biopharmaceutical company, but it is a particularly rare and exciting event in the neglected diseases setting” said Mark Sullivan, Founder and Managing Director of MDGH ( Medicine development for global).
Previously ,chemotherapy with ivermectin was the only drug approved by the FDA for onchocerciasis. Though Ivermectin significantly reduced the disease burden, but new treatment options are needed to accelerate progress toward eliminating parasite transmission. With the regulatory clearance under its belt, MDGH needs to work to make moxidectin accessible to everyone.