GlaxoSmithKline's Shingrix gets US FDA approval
GlaxoSmithKline said on Monday that the US Food and Drug Administration has approved Shingrix for the prevention of shingles in adults over 50.
FTSE 100
8,213.49
16:59 03/05/24
FTSE 350
4,515.50
16:54 03/05/24
FTSE All-Share
4,469.09
17:14 03/05/24
GSK
1,733.50p
16:49 03/05/24
Pharmaceuticals & Biotechnology
23,112.61
16:54 03/05/24
Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
Dr. Thomas Breuer, senior vice president and chief medical officer of GSK Vaccines, said the Shingrix vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects one in three people in the US.
“The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity," he said.
Glaxo said the approval is based on a comprehensive Phase III clinical trial program evaluating its efficacy, safety and immunogenicity in more than 38,000 people. In a pooled analysis of these studies, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of four years. By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia, a form of chronic nerve pain and the most common complication associated with shingles.
Luc Debruyne, president of Global Vaccines at GSK said: "We believe Shingrix will provide confidence in the protection one can expect from a shingles vaccine. GSK is committed to partnering with the public health and medical community to help address the gaps in vaccine coverage among adults that persist in the United States."