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HomeHealthMedicineEU Panel Backs New Drug for Infant Immunization of RSV

EU Panel Backs New Drug for Infant Immunization of RSV

The European Medicines Agency’s human medicines committee on Friday really helpful advertising and marketing authorization for an immunization in opposition to respiratory syncytial virus (RSV) for newborns and infants.

The company’s Committee for Medicinal Products for Human Use (CHMP) primarily based its constructive opinion for Beyfortus (nirsevimab) for prevention of decrease respiratory tract infections linked to RSV, the main reason for hospitalization amongst infants. The US Food and Drug Administration granted nirsevimab (MEDI8897 within the United States) a breakthrough remedy designation in February 2019, though the product continues to be within the medical trials stage and has not acquired advertising and marketing approval. 

RSV is the main reason for decrease respiratory tract infections in infants, based on a press launch from AstraZeneca and Sanofi, that are collectively growing the vaccine. 

Worldwide, acute decrease respiratory infections related to RSV account for about 1.4 million hospitalizations and 27,300 in-hospital deaths amongst infants below age 6 months yearly, according to the World Health Organization.

The extremely contagious virus can also be a priority for adults with compromised immune programs and older individuals with underlying well being circumstances, who’re at elevated threat for extreme illness. 

Nirsevimab is a long-acting antibody given as a single intramuscular injection at a dose of fifty mg for infants with a physique weight of lower than 5 kg, and 100 mg for infants weighing a minimum of 5 kg. 

The European authority primarily based its constructive opinion on outcomes from a number of trials, together with the part 3 MELODY research of practically 1500 infants, which reported a decreased incidence of medically attended decrease respiratory tract infections related to RSV with nirsevimab of 74.5% versus placebo (95% CI, 49.6, 87.1; P < .001). 

“Today’s positive CHMP opinion is one of the most significant public health achievements in respiratory syncytial virus in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems,” Jean-François Toussaint, PhD, international head of analysis and growth vaccines at Sanofi, mentioned in a statement in regards to the committee advice. “With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose.”

The advice will now be reviewed by the European Commission. If authorised, nirsevimab would be the solely preventative choice for the broad new child and toddler inhabitants, based on AstraZeneca and Sanofi. 

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