Mer­ck wins break­through ther­a­py des­ig­na­tion for po­ten­tial pneu­mo­coc­cal vac­cine suc­ces­sor

Less than a year af­ter win­ning FDA ap­proval for its next-gen­er­a­tion pneu­mo­coc­cal vac­cine last Ju­ly, Mer­ck is al­ready im­press­ing the agency with a po­ten­tial fol­low-up pro­gram.

Reg­u­la­tors be­stowed break­through ther­a­py des­ig­na­tion up­on Mer­ck’s V116 can­di­date, a 21-va­lent vac­cine de­signed to pre­vent in­va­sive pneu­mo­coc­cal dis­ease and pneu­mo­coc­cal pneu­mo­nia in adults. Mer­ck had turned in da­ta from a ran­dom­ized Phase I/II tri­al in pa­tients 18 and up for the agency’s re­view, and Phase III clin­i­cal tri­als for V116 are to be ini­ti­at­ed lat­er this year, the phar­ma said.

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