Source: [People's Daily Health Client] On September 16, the European Medicines Agency (EMA) Human Medicine Products Committee (CHMP) recommended the approval of Beyfortus for newborns and infants, helping them prevent RSV lower respiratory tract infections when the first respirat

Source: [People's Daily Health Client]

On September 16, the European Medicines Agency (EMA) Human Medicine Products Committee (CHMP) recommended the approval of Beyfortus for newborns and infants, helping them prevent RSV lower respiratory tract infections when the first respiratory syncytial virus (RSV) epidemic season arrives.

Once approved, Beyfortus will be the first and only single dose passive immunization preparation that can be widely used in infants, including healthy babies who are full-term or premature, or babies with special health conditions. Beyfortus is jointly developed by Sanofi and AstraZeneca. The positive opinions of

CHMP are based on the results of Beyfortus clinical studies, including phase III MELODY, phase II/III MEDLEY and phase IIb clinical studies. In the MELODY and Phase IIb studies, Beyfortus reached its primary endpoint, that a single dose of Beyfortus was used to reduce the incidence of lower respiratory tract infections (LRTIs) caused by RSV during the RSV epidemic season compared to placebo. Beyfortus has similar safety to placebo. In the Phase II/III MEDLEY study, Beyfortus also showed safety and tolerance comparable to Palivizumab.

Respiratory syncytial virus is the most common cause of lower respiratory tract infection and the primary causative factor leading to infant hospitalization worldwide, and most hospitalizations occur in healthy full-term infants. It is estimated that the global direct medical expenses associated with RSV (including inpatient, outpatient and follow-up care) will be 4.82 billion euros in 2017. Currently, there are no prevention programs for all infants, and treatment is limited to symptoms relief.

The head of global R&D of Sanofi vaccine said that CHMP's positive opinions are one of the most important public health achievements in the RSV field in decades and are expected to reduce the huge physiological and psychological burden that RSV brings to families and medical systems. Our goal is to provide RSV prevention to infants with a single dose of injection.

Iskra Reic, executive vice president of AstraZeneca Vaccine and Immunotherapy, said CHMP’s positive comments highlight Beyfortus’ potential to be a landmark, first-of-its-kind passive immune preparation and transform the way the entire medical community prevents RSV in the infant population.

Editor: Liu Meiyan

Editor: Xu Tingting

Proofreading: Li Xin

This article comes from [People's Daily Health Client] and only represents the author's views. The national party media information public platform provides information release and dissemination services.

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