Ze­ro­ing in on Mer­ck ri­val, GSK steps up to the FDA with its top new vac­cine prospect

Just weeks af­ter Glax­o­SmithK­line lined up a slate of promis­ing Phase III da­ta for its shin­gles vac­cine Shin­grix, the phar­ma gi­ant has filed its pitch with the FDA in search of an ap­proval that could gen­er­ate some sub­stan­tial rev­enue.

Glax­o­SmithK­line in­ves­ti­ga­tors have pa­tient­ly amassed con­sid­er­able da­ta for this prod­uct. The two-dose vac­cine post­ed a 90% ef­fi­ca­cy rate among pa­tients over 70 in one big Phase III that tracked pa­tients for 4 years. The pooled da­ta from two late-stage stud­ies hit 89% for peo­ple over 70 and 91% for those over 50.

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