By Chris Wack

 

GlaxoSmithKline Plc said the U.S. Food and Drug Administration has approved Shingrix for the prevention of shingles in adults aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.

The company said Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older.

Shingrix isn't indicated for prevention of primary varicella infection, or chickenpox. The approval for this new population expands the number of people who can be protected against shingles by Shingrix.

Glaxo said the approval for a new population was based on clinical studies examining the safety and efficacy of Shingrix in adults who had undergone an autologous hematopoietic stem cell transplant and those undergoing treatment for hematological malignancies.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

July 26, 2021 10:13 ET (14:13 GMT)

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