Drug Approval | May 12, 2023
USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
RSV is the most common viral cause of respiratory tract infections in newborns, young children, older adults, or the immunocompromised
RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available
Comirnaty, Pfizer’s COVID-19 prevention vaccine, reported global sales of $1.15 billion
Revenue increased 11.4 per cent to Rs. 8,545 crore
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
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