Health Canada accepted New Drug Submission (NDS) for Acadia’s Trofinetide to treat Rett Syndrome; also granted priority review
P-III LAVENDER study (n=187) evaluated safety and efficacy of Trofinetide in Rett Syndrome girls & young women; At wk12, co-1EP’s RSBQ score, and CGI-I score, were statistically significant; 2EP: statistically significant measuring improvements in communication
Trofinetide is currently not permitted for sale in Canada, but has been approved in US for adults and pediatric patients aged >2yrs
Ref: Health Canada | Image: Health Canada
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