Fatality in Phase I Clinical Study of E2082

Fatality in Phase I Clinical Study of E2082

TOKYO, Japan I July 30, 2019 I Eisai Co., Ltd. (“Eisai”) announced that a volunteer subject who took part in a Phase I clinical study for healthy adults in Japan died after completion of dosing study drug in June 2019. Eisai offers deepest sympathies and extends sincere condolences to the family of the subject.

The investigational drug used in the clinical study acts on the central nervous system and has the code name E2082.

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The relationship between the study drug and the subject’s death is unknown. In addition, as of today, no other serious adverse reactions have been reported in the clinical study. All use of E2082 in clinical studies has already been discontinued.

Eisai promptly reported the case to the Japanese Ministry of Health, Labour and Welfare, and it is actively cooperating with the investigation conducted by the Ministry.

Eisai views this tragic event as a very serious matter and will continue to strive to conduct all research and development activities with safety in mind and be guided by high ethical standards.

SOURCE: Eisai

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July 31, 2019 / Pharma News