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More Than 1 in 4 Novel New Drugs Approved by FDA in 2015 are Personalized Medicines


PMC Expert: Scientific Validation of Personalized Medicine’s Ability to Improve Patient Outcomes Driving Upward Trend in Approvals

WASHINGTON (January 21, 2016)

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A new analysis from the Personalized Medicine Coalition (PMC) documents an upward trend in the number of personalized medicine approvals at FDA, with personalized medicines accounting for more than 1 in 4 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 percent of the 45 NNDs the agency approved overall. The new approvals accelerate a trend PMC first noted in 2014, when the Coalition classified 21 percent of the year’s NNDs as personalized medicines.

PMC Science Policy Vice President Daryl Pritchard, Ph.D., 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,” Pritchard said. "The increasing number of approvals for these drugs reflects that progress.”

In addition to the increased number of NND approvals overall and for oncology specifically, the new analysis provides a description of how new indications and approvals for drugs that treat rare genetic disorders are expanding the list of treatment options that reflect advances in genomics and personalized medicine. Guided by these observations and data released last year by the Tufts Center for the Study of Drug Development suggesting that 42 percent of all drugs in development are personalized medicines, Pritchard said he believes the upward trend in approvals will continue.

"This is more than a passing trend,” Pritchard said. "Many people believe this is the future of medicine.”

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Contact:
Chris Wells
cwells@personalizedmedicinecoalition.org
Phone: 202-589-1755

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, please visit www.personalizedmedicinecoalition.org.

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