FDA panel backs GSK’s shingles vaccine

FDA’s Vaccines and Related Biological Products Advisory Committee voted 11-0 that available data support the safety and efficacy of Shingrix herpes zoster vaccine (HZ/su, GSK1437173A) from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to prevent shingles in adults ages 50 and older. GSK, which submitted the application last October, declined to disclose the PDUFA date.

GSK's BLA included data from the Phase III ZOE-50 and ZOE-70 trials in which Shingrix met the primary endpoint in both trials of reducing the risk of confirmed herpes zoster (shingles) cases vs. placebo. Specifically, Shingrix reduced the incidence of shingles cases by 97.2% and 89.8%, respectively (see BioCentury, Dec. 22, 2014 & Nov. 9, 2015)...