The European Medicines Agency’s human medicines committee on Friday recommended marketing authorization for an immunization against respiratory syncytial virus (RSV) for newborns and infants.
The agency’s Committee for Medicinal Products for Human Use (CHMP) based its positive opinion for Beyfortus (nirsevimab) for prevention of lower respiratory tract infections linked to RSV, the leading cause of hospitalization among infants. The US Food and Drug Administration granted nirsevimab (MEDI8897 in the United States) a breakthrough therapy designation in February 2019, although the product is still in the clinical trials stage and has not received marketing approval.
RSV is the leading cause of lower respiratory tract infections in infants, according to a press release from AstraZeneca and Sanofi, which are jointly developing the vaccine.
Worldwide, acute lower respiratory infections associated with RSV account for about 1.4 million hospitalizations and 27,300 in-hospital deaths among infants under age 6 months annually, according to the World Health Organization.
The highly contagious virus is also a concern for adults with compromised immune systems and older people with underlying health conditions, who are at increased risk for severe disease.
Nirsevimab is a long-acting antibody given as a single intramuscular injection at a dose of 50 mg for infants with a body weight of less than 5 kg, and 100 mg for infants weighing at least 5 kg.
The European authority based its positive opinion on results from several trials, including the phase 3 MELODY study of nearly 1500 infants, which reported a reduced incidence of medically attended lower respiratory tract infections associated with 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, global head of research and development vaccines at Sanofi, said in a statement about the committee recommendation. “With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose.”
The recommendation will now be reviewed by the European Commission. If approved, nirsevimab will be the only preventative option for the broad newborn and infant population, according to AstraZeneca and Sanofi.
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