GlaxoSmithKline's Shingrix Approved in the U.S. for Prevention of Shingles in Adults Aged 50 and Over
Pooled clinical trial results showed > 90 percent efficacy across all age groups
LONDON, Oct. 20, 2017 /PRNewswire/ -- GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. 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: "Shingrix represents a significant scientific advancement in the field of vaccinology. The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States.1 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."
Approval of Shingrix 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 4 years.2,3 By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), 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."
The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at its meeting on 25 October 2017.
Following this approval from FDA, and pending a recommendation from ACIP, Shingrix will be available shortly.
On 13 October 2017, Shingrix was approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older. Regulatory filings in the European Union, Australia and Japan are underway.
Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting or stabbing. 2,5 Even once the rash is gone, a person can experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.1 PHN is the most common complication of shingles, occurring in 10 to 18 percent of all shingles cases.1,6
There are an estimated 1 million cases of shingles in the United States each year.1 More than 99 percent of those over 50 years old are infected with VZV, and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older.1,7
Full US Prescribing Information will be available soon at www.us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Enquiries" section at the end of this document.
Shingrix Important Safety Information
SHINGRIX is not indicated for the prevention of chickenpox.
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1 Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30.
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