(CercleFinance.com) – Moderna today provided an update on regulatory submissions for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and diseases respiratory tract infections (ARD) in adults aged 60 years or older.
The Company has submitted marketing authorization applications for mRNA-1345 to the European Medicines Agency (EMA), Swissmedic in Switzerland and the Therapeutic Goods Administration (TGA) in Australia and launched the ongoing process of submitting a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for licensing of the mRNA-based RSV vaccine.
“We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia and the United States. RSV is a major cause of lower respiratory tract infections in the elderly and can place a significant burden on healthcare systems due to hospitalizations and emergency care admissions,’ said Stéphane Bancel, Director General of Moderna.
‘mRNA-1345 represents the second product from our mRNA platform to gain global approval, and with recent positive data in rare diseases and cancer, we expect more in the future – further demonstrating the enormous potential of mRNA to fight disease. ‘
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