Regulatory

FDA blesses Merck’s PhIII effort to topple a mega-blockbuster — but there’s also a little biotech in this game

Merck just got a leg up in its quest to leapfrog Pfizer’s best-selling pneumococcal conjugate vaccine Prevnar 13. The FDA is providing its breakthrough drug designation for the pharma giant’s late-stage efforts on V114, adding it to the VIP list for drugs tapped for swift handling.

V114’s claim to fame is that it does Pfizer’s Prevnar 13 two better in terms of the pneumococcus strains covered. 

Pfizer earns more than $6 billion a year from Prevnar 13, which came to the forefront after it upped the ante on pneumococcus strains that can be guarded against. Prevnar 13 is the world’s best-selling vaccine. 

But Merck and Pfizer aren’t the only player in this game. Little SutroVax claims it can go past the 20 mark on covered strains using tech for a conjugate vaccine that no other company can rival. And they’ve raised $170 million for that program.

Merck won BTD status by offering data from two mid-stage studies demonstrating that V114 protected infants against two disease-causing serotypes (22F and 33F) while appearing to be non-inferior to Prevnar 13 on the rest. The vaccine is currently in 2 late-stage studies for infants and adults.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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