The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN) Beyfortus (nirsevimab) is on course to be awarded priority review status for its use in preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter or are born during the first RSV infection season. The drug was previously awarded breakthrough therapy designation (BTD), highlighting its potential impact on public health.
Nirsevimab’s Efficacy in Reducing Hospitalizations
Nirsevimab, the first long-acting antibody for the prevention of RSV in babies, has been shown to reduce hospitalizations by 83.21% during the 2022-2023 RSV season in Europe compared to no RSV immunization. This figure is consistent with the 80% efficacy reported earlier this year from the latest real-world IIIb study, demonstrating the drug’s significant potential in reducing the burden of RSV infections.
Commercialization and Partnership Agreements
AstraZeneca agreed with Sanofi in March 2017 to take over development and preliminary regulatory filing rights to the drug, with Sanofi leading the commercialization efforts. In April this year, AstraZeneca, Sanofi, and Swedish Orphan Biovitrum (SOBI) simplified a commercialization agreement regarding the drug. Following a 2018 deal where Sobi purchased from AstraZeneca the right to participate in the US profits and losses for the drug, the updated terms state that Sobi will receive from Sanofi royalties for US sales while the liability for future obligations is eliminated.-Fineline Info & Tech
