has received marketing authorisation from Health Canada for DAYBUE (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Rett syndrome is a rare neurodevelopmental disorder that predominantly affects females. It is characterised by a significant regression in development after an initial two years of normal growth.
The majority of individuals with Rett syndrome will require lifelong, 24-hour care. The gold standard of business intelligence. The authorisation, under the priority review process, marks DAYBUE as the first and only drug approved in the country for this purpose.
Acadia CEO Catherine Owen Adams stated: “Health Canada’s authorisation of DAYBUE is a significant milestone for the Rett syndrome community in Canada and another step forward in Acadia’s commitment to increase access to this therapy for patients and their families. We look forward to bringing DAYBUE to Canadian patients with Rett syndrome as soon as possible.” The approval of DAYBUE in Canada is for use in patients who weigh a minimum of nine kilograms.
It was based on the positive outcomes from the Phase III LAVENDER trial. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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