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Approval process for 'Leqembi' heavily debated

By Lee, Hye-Kyung | translator Hong, Ji Yeon

24.10.14 05:47:17

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Rep. Jeon Jin-sook says approval in KOR has been granted without a review by the Central Pharmaceutical Affairs Council¡¦demands document submission until the comprehensive review


A heated debate is expected during the National Assembly regarding the approval process for Leqembi (lecanemab), a new drug for treating dementia that received domestic approval in May.

 ¡ãRep. Jeon Jin-sook, a member of the Democratic Party of Korea.

At a parliamentary audit of the Health and Welfare Committee held at the National Assembly on October 10th, Rep. Jeon Jin-sook, a member of the Democratic Party of Korea, issued an allegation that the approval of a new drug for dementia in South Korea has been granted without a review by the Central Pharmaceutical Affairs Council. This drug received a recommendation for non-approval from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) due to side effects.

"Althou

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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