Therapy Areas: AIDS & HIV
GlaxoSmithKline plc awarded FDA approval for Shingrix for prevention of shingles in immunocompromised adults across the US
27 July 2021 -

Healthcare company GlaxoSmithKline plc reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for Shingrix for the prevention of shingles (herpes zoster) in adults aged 18 years and older.

Shingles is caused by the reactivation of the varicella zoster virus (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, stated the company.

The FDA has approved the company's Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.

According to the company, Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by the US FDA for the prevention of shingles in adults 50 years of age or older. The approval for this new population expands the number of people who can be protected against shingles by Shingrix.

This US FDA approval for the new population was based on the company's clinical studies examining the safety and efficacy of Shingrix in adults (≥18 years of age) who had undergone an autologous hematopoietic stem cell transplant (auHSCT) and those undergoing treatment for hematological malignancies (post-hoc analysis). Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to HIV, solid tumors and renal transplants.

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