Large Molecule

FDA Panel Green-lights GSK Shingles Vax

Sep 14, 2017

GlaxoSmithKline announced that its Shingrix vaccine has won the support of an FDA Advisory Committee.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over.

GSK submitted the BLA to the FDA in October 2016, and the vaccine is slated for an October 2017 action date. The company says regulatory filings in the European Union, Canada, Australia and Japan are underway.

Read the GSK press release