Daiichi Sankyo submits application for marketing approval of mRNA COVID vaccine DS-5670 in Japan

Published On 2023-01-15 03:30 GMT   |   Update On 2023-01-15 03:30 GMT
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Tokyo: Daiichi Sankyo has announced the submission of an application for marketing approval of DS-5670 to the regulatory authorities in Japan.

DS-5670 is an mRNA vaccine, being developed against the novel coronavirus infectious disease (COVID-19) and is proposed to be used as a booster vaccine for the prevention of COVID-19.

The application is based on results of a phase 1/2/3 trial (original strain) in approximately 5,000 healthy adult and elderly subjects, who received the primary series (two doses) of an mRNA vaccine approved in Japan.

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Daiichi Sankyo started prior assessment consultations for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available up to now to obtain marketing approval at an earlier date.

In addition, Daiichi Sankyo plans to move forward with the development of DS-5670 for the Omicron strain in order to respond to new variants of the coronavirus, which continue to mutate, in parallel with the development for the original strain. 

DS-5670 is an mRNA vaccine against COVID-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo, designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus. 

Read also: Daiichi Sankyo unveils Blood cancer drug EZHARMIA in Japan

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