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EMA Committee recommends nod of Sanofi, AstraZeneca Beyfortus for prevention of RSV disease in infants

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-09-18T15:00:07+05:30  |  Updated On 18 Sept 2022 3:00 PM IST
EMA Committee recommends nod of Sanofi, AstraZeneca Beyfortus for prevention of RSV disease in infants
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Paris: Sanofi and AstraZeneca have recently announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. If approved, Beyfortus would be the first and only single-dose passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca.

Jean-François Toussaint, Global Head of Research and Development Vaccines, Sanofi said, "The positive CHMP opinion is one of the most significant public health achievements in RSV in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems. With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose."

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca said, "This positive CHMP opinion underscores Beyfortus' potential as a ground-breaking, first-in-class passive immunization that could transform the medical community's approach to RSV prevention in infants."

The CHMP based its positive opinion on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY, and Phase 2b trials. In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose. The safety profile of Beyfortus was similar to placebo. Beyfortus also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.

RSV is the most common cause of LRTIs and a leading cause of hospitalization in all infants, with most hospitalizations occurring in infants born healthy and at term.9-13 RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017. Currently there is no preventative option available for all infants and treatment is limited to symptomatic relief.

Read also: Sanofi gets USFDA nod for ASMD drug Xenpozyme

sanofisanofi newsAstraZenecaAstraZeneca newsBeyfortusnirsevimab
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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