The advisers voted unanimously in favor of using the antibody, nirsevimab, in newborns and infants to prevent infections in their first RSV season.
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Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.
Sobi has announced a streamlining and simplification of the contractual economics for nirsevimab through a new royalty agreement with Sanofi and the termination of the participation agreement with AstraZeneca.
Pfizer notched another score in the race for an RSV vaccine Tuesday, as it announced the FDA has accepted the Biologics License Application for its maternal RSV vaccine and granted the candidate priority review.
Sanofi’s global head of R&D, John Reed, is leaving his position to pursue another opportunity outside the company, the French multinational announced Monday.
The European Commission has approved Sanofi and AstraZeneca’s Beyfortus for the prevention of a common and highly contagious type of respiratory infection in infants.
AstraZeneca said on Friday its drug for preventing infant RSV, Beyfortus (nirsevimab), was recommended for approval in the European Union by a European Medicines Agency committee.