Daiichi Sankyo has submitted an application to the regulatory authorities in Japan seeking marketing approval of DS-5670.
DS-5670 is an mRNA vaccine being developed against the novel coronavirus infectious disease (COVID-19).
It is proposed to be used as a booster vaccine to prevent Covid-19.
The firm submitted the application backed by results of a Phase I/II/III trial (original strain) in around 5,000 healthy adult and elderly subjects, who received the primary series (two doses) of an mRNA vaccine approved in the country.
Daiichi Sankyo earlier began evaluation 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 in order to secure marketing approval at an earlier date.
Furthermore, Daiichi Sankyo intends to proceed ahead with the development of DS-5670 for the Omicron strain to respond to new variants of the coronavirus in parallel with the development for the original strain.
Daiichi Sankyo is striving to develop mRNA-vaccine-associated technologies and the production and supply system in Japan to ensure a quick provision of vaccines in the event of outbreaks of emerging and reemerging infectious diseases.