Leaders in Pharmaceutical Business Intelligence (LPBI) Group

More Than 25 Percent of the Novel New Drugs Approved by FDA in 2015 are Personalized Medicines

Reporter: Aviva Lev-Ari, PhD, RN

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.”

SOURCE

http://www.pharmpro.com/news/2016/01/many-novel-drugs-approved-fda-2015-are-personalized-medicines

2015 Progress Report Personalized Medicine at FDA

More Than 25 Percent of the Novel New Drugs Approved by FDA in 2015 are Personalized Medicines

The transformation of health care from one-size-fits-all, trial-and-error medicine to a targeted approach utilizing an individual patient’s molecular information continues to accelerate as the U.S. Food and Drug Administration (FDA) more regularly and rapidly approves new personalized medicines. FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel new drugs (NNDs), either

new molecular entities or new therapeutic biologics, in 2015. Of these 45 NNDs, 13 of them — more than 25 percent — were personalized medicines as classified by the Personalized Medicine Coalition (PMC), thus continuing a trend that began last year when nine of 41 NNDs were classified as personalized medicines.

SOURCE

http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/2015_Progress_Report_PM_at_FDA.pdf