Moderna’s RSV vaccine gains expedited approval

The Ministry of Food and Drug Safety (MFDS) announced on the 18th that it has approved mRESVIA Prefilled Syringe (respiratory syncytial virus [RSV] mRNA vaccine, Moderna Korea) as the first biologic drug to be authorized under the newly implemented ‘New Drug Marketing Authorization and Review Procedures’ implemented this year.

The revised New Drug Marketing Authorization and Review Procedures, introduced earlier this year, include expedited review measures such as the formation of dedicated product review teams and prioritizing GMP reviews. These measures were established as follow-up actions to the increase in new drug approval review fees.

For the approval of mRESVIA, the MFDS formed a dedicated review team consisting of 18 members, including specialists in new drug evaluation, conducted priority GMP reviews, and held individualized face-to-face meetings before and after the marketing authorization application. Through close communication with the applicant, the MFDS was able to complete the approval process in an expedited manner.

The newly approved imported drug, mRESVIA Prefilled Syringe, is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older, as well as in high-risk individuals aged 18 to under 60 years. It is the first RSV preventive vaccine in Korea approved using an mRNA platform.

Respiratory syncytial virus (RSV) is a virus that causes acute respiratory infections with symptoms similar to those of the common cold.

Meanwhile, the first small-molecule drug approved under the new fast-track review system was Xcopri Tab (cenobamate) developed by Dong-A ST, which received marketing authorization in November.

The MFDS stated that it plans to further enhance the new drug review system through in-depth preliminary assessments, item-by-item parallel reviews, and stage-specific tailored meetings during the new drug approval process. These efforts aim to facilitate rapid market entry of innovative medicines, provide patients with quicker access to treatment options, and support the growth of the biopharmaceutical industry.