GSK’s Shingrix Gets Positive CHMP Opinion For Prevention Of Shingles

January 30, 2018  Source: rttnews 548


GlaxoSmithKline plc (GSK,GSK.L) said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending marketing authorisation for Shingrix (RELATED: CDC backs GSK’s Shingrix over Merck & Co’s Zostavax) for the prevention of shingles, or herpes zoster, and post-herpetic neuralgia or PHN.

Shingles and PHN are the most common and often painful shingles-related complication, in adults aged 50 years or older

Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses, with a two-to-six month interval between doses. It is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response

A CHMP positive opinion is one of the final steps before Marketing Authorisation is granted by the European Commission or EC. A final decision by the EC is anticipated in April 2018.


Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said, "The risk of developing shingles increases with age and it is estimated that around one in three people will develop shingles in their lifetime. Shingrix is specifically designed to overcome the age-related weakening of the immune system and is an important step forward in the prevention of shingles."Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes chickenpox. A person's risk for shingles increases sharply after 50 years of age. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age.

By Ddu
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