AstraZeneca And Sanofi March Ahead With Positive Phase III RSV Data
MELODY Data Music To Companies’ Ears
AstraZeneca and Sanofi have leapt forward in their plans to shake up the RSV market with earlier than expected positive data for their passive immunization product nirsevimab. Rival maternal vaccines in development will cast a shadow, however.
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Pfizer’s bivalent vaccine candidate showed efficacy in RSV patients with multiple respiratory infection symptoms and may offer protection against the A and B strains of the virus.
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.
New maternal/pediatric work group will consider recommendations for use of RSV vaccines and monoclonal antibodies targeting protection of children <18 years. With several products in the late-stage pipeline, group has begun reviewing RSV epidemiology and discussing cost-effectiveness.