AstraZeneca-Sanofi Beyfortus approved in Japan for prevention of RSV disease in infants

Beyfortus is the preventive option developed to protect a broad infant population against RSV LRTD, including protecting those infants born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe disease. The approval by the Japanese Ministry of Health, Labour and Welfare is based on three Beyfortus pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD extending through five months, the duration of a typical RSV season.

More than 100,000 cases of RSV LRTD in infants are reported every year in Japan including healthy infants born at term.

Dr. Hiroyuki Moriuchi, Professor and Head of Department of Pediatrics, Nagasaki University Graduate School of Biomedical Sciences, said, “This is an important milestone in the fight against RSV in infants. Almost all children are affected by RSV by the age of two and all infants, including those born healthy and at term, can be at risk. RSV causes a significant burden for children, their families and to the medical system potentially leading to long-term consequences of severe infection in infancy. Beyfortus can protect infants across the RSV season and its approval represents a crucial contribution to the prevention and control of RSV disease in Japan.”

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said, “The approval of Beyfortus means it is possible for the first time to prevent serious respiratory disease due to RSV for all infants in Japan and reduce the infectious disease burden on healthcare systems. Beyfortus reflects AstraZeneca’s commitment to the scientific development of preventive options to support the most vulnerable patient populations and we look forward to making Beyfortus available in Japan for the 2024/25 season.”

Beyfortus has received approval in the European Union, US and China.

Japan Beyfortus indication

The following groups of neonates, infants or children at risk of serious RSV infection entering their first or second RSV season, should meet at least one of the following criteria:

• In the early stage of first RSV season

o Infants born at 28 weeks’ gestation or earlier and less than 12 months of age

o Infants born at 29 to 35 weeks' gestation and less than 6 months of age

• In the early stage of first and second RSV season

o Neonates, infants or children less than 24 months of age who have received one treatment against chronic lung disease within the past 6 months

o Neonates, infants or children less than 24 months of age with hemodynamically significant congenital heart disease

o Neonates, infants or children less than 24 months of age with immunocompromised conditions

o Neonates, infants or children less than 24 months of age with Down syndrome

Beyfortus (nirsevimab) is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca’s YTE technology. 

Beyfortus has been granted regulatory designations to facilitate expedited development by several major regulatory agencies around the world. These include Breakthrough Therapy Designation and Priority Review Designation by the China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA PRIority MEdicines (PRIME)) scheme; and named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED).

In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialise nirsevimab. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities and records revenue. The two companies share costs and profits in all territories except the US. AstraZeneca's revenue from the agreement is reported as Alliance Revenue and Collaboration Revenue in the Company’s financial statements.

Following a revision to the profit-sharing arrangement relating to the development and commercialisation of nirsevimab in the US between AstraZeneca, Sanofi and Sobi, Sobi has entered into a direct relationship with Sanofi, replacing the previous participation agreement with AstraZeneca entered into in November 2018.

Beyfortus will be co-promoted by AstraZeneca and Sanofi in Japan.

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