On January 17, 2022, GlaxoSmithKline’s headquarters in London, England.
Hannah McKay | Reuters
The Food and Drug Administration expanded approval Friday GSKRespiratory syncytial virus vaccine is available for adults aged 50 to 59 who are at increased risk of infection Serious illness from potentially deadly viruses.
The vaccine, Arexvy, is the first vaccine approved by the FDA to protect people from RSV infection. The agency first approved GlaxoSmithKline’s (GSK) vaccine for use in patients in May 2023 Over 60 years oldthey are more susceptible to severe cases of the virus.
RSV reportedly causes thousands of hospitalizations and deaths in older adults each year data From the Centers for Disease Control and Prevention. But the virus can also cause serious illness in adults age 50 and older, and even younger, with underlying chronic conditions such as asthma, diabetes and congestive heart failure.
Phil Dormitzer, director of vaccine development and infectious disease research at GlaxoSmithKline, said in an interview that approximately 13 million Americans aged 50 to 59 are at high risk of severe disease from RSV.
“It’s useful because, of course, you can address the medical needs of that age group, but it’s also nice for pharmacists to have a single vaccine that can be administered to a broader population, so that provides simplicity.”
GlaxoSmithKline’s vaccine is not yet able to cover new patient groups. A CDC advisory panel will vote later in June on recommendations for GlaxoSmithKline’s vaccine, as well as the company’s competing shots. Pfizer and newly approved vaccines modern.
The expanded FDA approval could help Glaxo maintain its dominance of the RSV market later this fall and winter, when the virus will dominate the market. Usually spread widely The British drugmaker had US sales of around £1.2bn last year, more than $890m (£699m) Revenue from the Pfizer vaccine.
GlaxoSmithKline (GSK) chief commercial officer Luke Miels said on an earnings call in May that the company Still ‘very confident’“Over time, Arexvy’s peak annual sales will exceed £3 billion.
Domize said Glaxo had success last RSV season but noted the company would always “take competition seriously”.
He said Arexvy showed strong efficacy in patients with underlying conditions.
In a late-stage trial, a single dose of the vaccine triggered an immune response in high-risk adults ages 50 to 59 that was no more severe than that seen in people 60 and older.
A previous late-stage trial in older age groups found the vaccine was nearly 83% effective in preventing lower respiratory tract illness caused by RSV and about 94% effective in preventing severe disease.
Safety data for adults aged 50 to 59 years were also consistent with those for adults aged 60 and over, GSK said. Side effects include fatigue, headache, and muscle pain, and are mostly mild to moderate in severity.
Single-dose GSK shot only slightly less effective in adults 60 and older after two seasons of virus Effectiveness 67.2% Prevent lower respiratory tract diseases. Domizer said the company will test the vaccine’s efficacy over three RSV seasons to see if it provides longer protection.
GSK is also studying Arexvy in other patient groups to expand the scope of future injections. The company expects to release data from the trial later in 2024 for two different patient groups: those ages 18 to 59 who are at higher risk for severe RSV, and adults with weakened immune systems.
The company is also expanding the vaccine’s coverage in other countries, Domizer added. Regulators in Europe, Japan and elsewhere are currently reviewing GlaxoSmithKline’s application to expand approval of Arexvy to high-risk adults aged 50 to 59.
A GSK spokesperson told CNBC that the vaccine has been approved in nearly 50 countries.
About The Author
