the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating condition," said Catherine Owen Adams, Acadia’s Chief Executive Officer. “Our commitment is to make a meaningful difference in the lives of patients, caregivers, and the wider Rett community by addressing this significant unmet need, and we are very pleased with the outcome of the re-examination process."

The CHMP’s recommendation is primarily based on results from the Phase 3 LAVENDER™ study, which demonstrated statistically significant and clinically meaningful improvements in core features of Rett syndrome, as measured by the Rett Syndrome Behaviour Questionnaire (RSBQ) and Clinical Global Impression-Improvement (CGI-I) scale. Importantly, these findings indicate that treatment with DAYBU® can address some of the most impactful aspects of Rett syndrome, which severely impact quality of life for patients and caregivers.


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