Shots:

• The approval is based on two clinical studies results assessing Moxidectin vs SoC Ivermectin in patients with river blindness aged ≥ 12 yrs.
• The study resulted in meeting 1EPswith superiority of Moxidectin vs SoC Ivermectin and resulted in suppression of microfilariae in the skin
• Moxidectin (8mg- PO) is macrocyclic lactone anthelmintic medication active against O.volvulus microfilariae and has also received FDA’s PRV on 13 Jun- 2018 with its accelerated NDA review from 10 to 6mos.

Ref: Medicines Development for Global Health | Image: CmocroI