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Approval of Beyfortus imminent in Korea

By Lee, Hye-Kyung | translator Kim, Jung-Ju

24.04.06 05:50:28

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MFDS CPAC review results show that Beyfortus¡¯s approval is feasible with bridging data



Beyfortus (nirsevimab), a long-acting antibody designed to prevent respiratory syncytial virus (RSV) in infants that was jointly developed by Sanofi and AstraZeneca, is soon to receive marketing authorization in Korea.

According to the minutes of the Central Pharmaceutical Affairs Council meeting held on March 6, which was released by the Ministry of Food and Drug Safety on the 5th, the members discussed the "feasibility of granting marketing authorization based on the submitted data, which includes bridging data¡± for an RSV vaccine and concluded that it was ¡°feasible¡±

Although the name of the product was not disclosed in the minutes, the discussed item appears to be Beyfortus, which

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