AstraZeneca (NASDAQ:AZN) stated that Beyfortus was now the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or pre-term, or with specific health conditions.
The FTSE 100-listed group said the European Commission was the first regulatory body to grant approval to Beyfortus, with the approval based on results from the drug's clinical development programme and follows a recommendation from The Committee for Medicinal Products for Human Use of the European Medicines Agency in September.
In AZN's "pivotal" MELODY efficacy trial, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections caused by RSV by 74.5% versus placebo through day 151 with a single dose.
Iskra Eric, AZN's executive vice president of vaccines and immune therapies, said: "Beyfortus is the first single-dose preventative option against respiratory syncytial virus to gain approval in Europe and is also the first and only preventative option approved for a broad infant population.
"Today's marketing authorisation of Beyfortus marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention."
Reporting by Iain Gilbert at Sharecast.com