In some embodiments, the otic formulation or composition comprises between about 1% to about 20% by weight of the therapeutic agent, or pharmaceutically acceptable prodrug or salt thereof
The accelerated approval for Eisai and Biogens Leqembi (lecanemab) was converted to a full approval based on results from the confirmatory Clarity-AD trial, which the FDA said in its statement verified the drugs benefit
The practical consequence is that identity and activity can diverge for this molecule: material could assay as present while having partially converted to a form the founding paper reported as far less active
Int Biodeter Biodegr 117:205214 Yang T, Ren L, Jia Y, Fan S, Wang J, Wang J, Nahurira R, Wang H, Yan Y (2018) Biodegradation of Di-(2-ethylhexyl) phthalate by Rhodococcus ruber YC-YT1 in contaminated water and soil
Vitamin C is often suggested as a companion because it may help maintain glutathione in its active, reduced form
Ecotoxicol Environ Saf