One of Merck’s next generation pneumococcal vaccines has been granted breakthrough therapy status by the FDA, as the Big Pharma races rival Pfizer to market.
V116—one of three pneumococcal vaccines in Merck’s clinical pipeline—targets serotypes that account for 85% of cases of invasive pneumococcal disease among individuals aged 65 and over in the U.S., including eight serotypes not currently covered by any licensed vaccines. The company expects to begin phase 3 trials later this year.
The FDA’s decision was informed by data from a randomized, double-blind phase 1 study that assessed safety, tolerability and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults aged 18-49 years of age, and a phase 2 trial of over-50s. Full results are due to publish in June.
“We look forward to discussing the ongoing development of this investigational vaccine, including the approach for phase 3 studies, with the FDA and other regulatory agencies,” Eliav Barr, M.D., senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in a statement.
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