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GSK Announces Unanimous FDA Approval For Shingrix In Over 50s - Quick Facts

GlaxoSmithKline Plc (GSK.L,GSK) announced Thursday that the Vaccines and Related Biological Products Advisory Committee or VRBPAC of the US Food and Drug Administration voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster or shingles in adults ages 50 and over.

FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA.

Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK said, "Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today's vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system."

The Biologics License Application was submitted to the FDA in October 2016.

GSK said its shingles candidate vaccine is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway.

The candidate vaccine is a non-live, recombinant subunit vaccine to help prevent herpes zoster (shingles) and its complications, such as postherpetic neuralgia, in adults 50 years of age and older.

Shingles is caused by varicella zoster virus or VZV, the same virus that causes chickenpox. Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.

by RTTNews Staff Writer

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