A view shows GlaxoSmithKline’s headquarters in London, Britain, January 17, 2022.
Hannah Mckay | Reuters
The Food and Drug Administration on Friday expanded approval of GSKThe respiratory syncytial virus vaccine is given to adults ages 50 to 59 who are at increased risk of becoming seriously ill from the potentially deadly virus.
The vaccine, called Arexvy, is the first FDA-approved vaccine to protect this population from RSV. The agency first approved the GSK vaccination in May 2023 for patients aged 60 and over, who are more susceptible to severe cases of the virus.
RSV causes thousands of hospitalizations and deaths among seniors each year, according to data from the Centers for Disease Control and Prevention. But the virus can also cause severe illness in adults age 50 and older – or even younger – with underlying chronic conditions such as asthma, diabetes and heart failure.
About 13 million Americans ages 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 both because you can obviously meet the medical needs of this age group,” Dormitzer told CNBC, “but it’s also nice for pharmacists to have a single vaccine that they can administer to a larger population, what simplicity ensures.” .”
GSK’s vaccination will not yet reach this new patient group. A CDC advisory panel will vote on recommendations for GSK’s vaccine and a competing vaccine later in June Pfizer and a newly approved jab of Modern.
The FDA’s expanded approval could help GSK maintain its dominance in the RSV market later this fall and winter, when the virus typically continues to spread in the United States. The British drugmaker posted sales of around 1.2 billion pounds last year, surpassing sales of $890 million (about 699 million pounds) in revenue generated by the Pfizer vaccine.
Luke Miels, GSK’s chief commercial officer, said on a conference call in May that the company remained “very confident” that Arexvy could generate peak annual sales of more than £3 billion over time.
Dormitzer said GSK had a successful final RSV season, but stressed that the company will “always take the competition seriously.”
He said Arexvy has shown strong effectiveness in patients with pre-existing conditions.
In a late-stage study, a single dose of the vaccine in high-risk adults ages 50 to 59 triggered an immune response no worse than that seen in people ages 60 and older.
A previous late-stage study in this older age group found the vaccine was nearly 83% effective in preventing lower respiratory tract disease caused by RSV and about 94% effective in preventing severe disease.
According to GSK, the safety data in adults aged 50 to 59 years was also consistent with the data in adults aged 60 and over. Side effects included fatigue, headache and muscle pain, which were mostly mild to moderate in severity.
A single dose of the GSK shot was only slightly less effective in adults 60 and older after two seasons of infection, showing 67.2% effectiveness against lower respiratory tract disease. Dormitzer said the company will test the vaccine’s effectiveness over three RSV seasons to see if it can provide even longer protection.
GSK is also studying Arexvy in other patient populations to expand the shot’s reach in the future. The company is expected to announce trial data later in 2024 in two separate patient groups: people ages 18 to 59, who are at increased risk of severe RSV, and adults with compromised immune systems.
Dormitzer added that the company is expanding the shot’s reach in other countries as well. Regulators in Europe, Japan and other regions are currently reviewing GSK’s application to expand approval of Arexvy to high-risk adults ages 50 to 59.
GSK’s shot is approved in nearly 50 countries, a company spokesperson told CNBC.
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2024-06-07 22:21:42
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