RSV Seasonal Vaccine Introduction and Growth Strategy
Changes since Q1 2023
Changes on pipeline
New to Phase II
4348413 - GMMA, gonorrhea
3858279
Anti-CCL17 antibody, osteoarthritis pain **
Achieved pipeline catalysts
Regulatory submissions & acceptances
Jemperli - RUBY, dMMR/MSI-H IL endometrial cancer
Menveo - liquid formulation, Men ACWY
New to Phase III
ibrexafungerp - Antifungal glucan synthase inhibitor, invasive candidiasis
camlipixant - P2X2/P2X3 receptor antagonist, refractory chronic cough
Regulatory decisions
Arexvy - Adjuvanted recombinant protein, RSV older adults
Shingrix 18+ at increased risk of HZ
Removed from Registration
SKYCovione - Recombinant protein nanoparticle, adjuvanted, COVID-19
daprodustat - Prolyl hydroxylase inhibitor, anaemia of chronic kidney disease
GSK
**
Additional indications or candidates also under investigation
1. Tesaro asset
Other events
Infectious diseases
HIV (VIIV)
Respiratory/Immunology
Oncology
Opportunity driven
US
EU
JP
SS
US, EU
-
MenABCWY Phase III data presentation at ESPID
4348413 - GMMA, gonorrhea - FDA Fast Track Designation
cabotegravir (long-acting) pre-exposure Positive CHMP opinion
-
3858279 - Anti-CCL17 antibody, osteoarthritis pain - FDA Fast Track Designation
3858279 - Anti-CCL17 antibody, diabetic peripheral neuropathic pain - FDA Fast Track Designation
Jemperli - RUBY, dMMR/MSI-H 1L endometrial cancer - FDA Priority Review
Jemperli - RUBY, DMMR/MSI-H IL endometrial cancer FDA Breakthrough Designation
daprodustat - Positive CHMP opinion
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