GSK’s Shingrix Receives the US FDA’s Approval to Prevent Shingles in Immunocompromised Adults

July 27, 2021 Auto Bot approval, FDA, GSK, regulatory, Shingrix 0

Shots:

  • The approval is based on studies evaluating the safety & efficacy of Shingrix in adults aged ≥18yrs. who had undergone auHSCT and those undergoing treatment for hematological malignancies (post-hoc analysis)
  • The safety & immunogenicity data were generated in adults who were or anticipated to be, immunodeficient/immunosuppressed due to known therapy including patients with HIV, solid tumors, and renal transplants
  • Shingrix (IM, 2 doses) is a non-live, recombinant sub-unit adjuvanted vaccine, initially approved for the prevention of shingles in adults aged ≥50yrs. in the US. The approval for this new population expands the number of people who can be protected against shingles

Click here ­to­ read full press release/ article | Ref: GSK | Image: Bloomberg Quint

The post GSK’s Shingrix Receives the US FDA’s Approval to Prevent Shingles in Immunocompromised Adults first appeared on PharmaShots.