Moderna Announces FDA's Breakthrough Designation For MRNA-1345; Plans License Application In H1

Moderna, Inc. (MRNA) announced mRNA-1345 has been granted Breakthrough Therapy Designation by the FDA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years or older. The designation was based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial.

mRNA-1345 is an investigational RSV vaccine, which uses the same lipid nanoparticles as in the Moderna COVID-19 vaccines. It was granted Fast Track designation by the FDA in August 2021. The company plans to submit a license application for regulatory approval in the first half of 2023.

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT