Over 1 in 4 new drugs approved by FDA in 2015 are personalized medicines

A new analysis from the Personalized Medicine Coalition (PMC) documents an upward trend in the number of personalized medicine approvals at the US Food and Drug Administration, with personalized medicines accounting for more than one in four novel new drugs (NNDs) approved in 2015.

The analysis, titled  2015 Progress Report: Personalized Medicine at FDA, lists the 13 personalized medicines approved as NNDs in 2015, which represent 28% of the 45 NNDs the agency approved overall. The new approvals accelerate a trend PMC first noted in 2014, when the Coalition classified 21% of the year’s NNDs as personalized medicines.

PMC science policy vice president Daryl Pritchard said the momentum is driven by scientific validation of personalized medicine’s ability to improve patient outcomes. "The scientific community has established personalized medicine as a successful approach to treating many diseases,” said Dr Pritchard, adding: "The increasing number of approvals for these drugs reflects that progress.”