In Brief: Merck's Mectizan

Executive Summary

Merck's Mectizan: Ivermectin oral 6 mg tablets approved Nov. 25 for treatment of strongyloidiasis of GI tract and onchocerciasis (river blindness), FDA announces Nov. 25. In controlled clinical trials, a single dose of ivermectin cured between 64% and 100% of patients infected with intestinal strongyloidiasis; in onchocerciasis patients, ivermectin reduced number of larvae in skin an average of 83.2% at three days and 99.5% at three months after a single dose, according to an FDA "Talk Paper." Mectizan was deemed "approvable" at FDA Oct. 8; Merck filed an NDA for the indications in March ("The Pink Sheet" Oct. 21, In Brief)...