A view of the GlaxoSmithKline headquarters in London, UK, January 17, 2022.
Hannah McKay | Reuters
The Food and Drug Administration on Friday expanded its authorization to GSKvaccine against respiratory syncytial virus for adults aged 50 to 59 who are at increased risk of developing the disease really ill from a potentially deadly virus.
The shot, called Arexvy, is the first vaccine approved by the FDA to protect this population against RSV. The agency first approved GSK’s vaccine for patients in May 2023 60 and morewho are more susceptible to severe cases of the virus.
According to data, RSV causes thousands of hospitalizations and deaths among seniors every year data from the Centers for Disease Control and Prevention. However, the virus can also cause severe illness in adults aged 50 and older – and even younger – with chronic conditions such as asthma, diabetes and congestive heart failure.
About 13 million Americans aged 50 to 59 are at high risk of severe disease from RSV, Phil Dormitzer, head of vaccine research and development and infectious disease research at GSK, said in an interview.
“It’s useful for both reasons because obviously you can meet the medical needs of this age group,” Dormitzer told CNBC, “but it’s also good for pharmacists to have one vaccine that they can give to a broader population, which keeps things elementary.”
The GSK vaccine will not yet reach this fresh patient population. In behind schedule June, a CDC advisory panel will vote on recommendations for GSK’s vaccine along with the company’s rival vaccine Pfizer and newly approved vaccination from State-of-the-art.
Expanded FDA approval could lend a hand GSK maintain its dominance in the RSV market well into the fall and winter when the virus usually spreads more widely in the US Sales of the British drugmaker’s shot were around £1.2 billion last year, surpassing $890 million (around £699 million) revenue earned by the Pfizer vaccine.
GSK Chief Commercial Officer Luke Miels said on an earnings call in May that the company he remains “very confident“that Arexvy could, over time, deliver peak annual sales of over £3 billion.
Dormitzer said GSK’s last RSV season was successful, but noted that the company will always “take the competition seriously.”
He said Arexvy has shown high effectiveness in patients with comorbidities.
In a late-stage study, a single dose of the shot produced an immune response in high-risk adults aged 50 to 59 that was no worse than that seen in people aged 60 and older.
A previous late-stage study in this older age group found the shot was almost 83% effective at preventing lower respiratory tract disease caused by RSV and about 94% effective at preventing severe disease.
According to GSK, safety data in adults aged 50 to 59 years were also consistent with data in adults aged 60 years and over. Side effects included fatigue, headache and muscle pain, most of which were bland to moderate in severity.
A single dose of the GSK vaccine was only slightly less effective in adults aged 60 and older after two seasons of the virus, findings showed Effectiveness 67.2%. against lower respiratory tract diseases. Dormitzer said the company will test the vaccine’s effectiveness over three seasons of RSV infection to see if it provides even longer protection.
GSK is also testing Arexvy in other patient groups to expand the shot’s reach in the future. The company is expected to announce study data in behind schedule 2024 for two distinct patient groups: people ages 18 to 59 who are at increased risk of severe RSV infection, and adults with weakened immune systems.
Dormitzer added that the company is also expanding the shot to other countries. Regulatory agencies in Europe, Japan and other areas are currently reviewing GSK’s application to extend approval of Arexvy to high-risk adults aged 50 to 59.
GSK’s shot has been approved in nearly 50 countries, a company spokesperson told CNBC.
