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Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis.
Capvaxive’s approval was partially based on data from four Phase III trials including the STRIDE-3 study, which found that the vaccine was non-inferior to comparator vaccine Prevnar 20. According to a November 2023 readout, Capvaxive also elicited superior immuneresponses for ten of the 11 serotypes not covered by Prevnar 20.
What’s more, VAX-24 achieved a higher immuneresponse to 16 of the 20 serotypes it shares with Prevnar 20. The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.
Clinical Data Supporting Approval Demonstrated Non-Inferior ImmuneResponses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior ImmuneResponses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.
The biotech is eligible to receive a further $125 million if the FDAapproves the drug and could receive another $225 million in commercial milestones. If approved by the FDA, the treatment would become the first microbiome-based treatment to receive approval. Compelling advantages.
Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDAapproval, the U.S.
Developing a highly effective vaccine against malaria has been technically challenging because malaria has a large and complex genome, and it’s why it’s generally more difficult to develop a vaccine against parasites than smaller viruses and bacteria.
In September, Corbus Pharmaceuticals Holdings announced topline results from its 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc), a rare life-threatening multi-system autoimmune disease for which there are no FDA-approved treatments.
Fabhalta works by inhibiting factor B, a key enzyme in the alternative complement pathway, thus calming the damaging immuneresponse. Due to a risk of serious infections from encapsulated bacteria, its use is limited to a Risk Evaluation and Mitigation Strategy requiring specific vaccinations.
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