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FDA Approved

The US Food and Drug Administration hit a new record in its personalized medicine approvals last year, according to the Personalized Medicine Coalition.

Out of 45 new drugs approved by the FDA last year, 13 treatments — or 28 percent —are personalized medicines, the PMC says in a statement. In comparison, in 2014, nine out of 41 new drugs, or 22 percent of treatments, the agency approved were personalized.

The PMC issued the list with input from the FDA. The group considered drugs "personalized" whenever product labeling included a "reference to specific biological markers" that may be gauged by diagnostic tools and which guide decisions or procedures in patients.

GenomeWeb also published a list of 2015 personalized drug approvals, but applied different criteria and considered drugs indicated in labeling for a molecularly defined patient subset and those for which a companion or complementary diagnostic was approved with the drug. GenomeWeb also included previously approved drugs with new personalized medicine indications, such as Opdivo and Iressa.

Drugs that showed up in PMC's list but not ours include Cholbam (cholic acid), Praluent (alirocumab), Repatha (evolocumab), Rexulti (brexpiprazole), Aristada (aripiparazole lauroxil), and Nucala (mepolizumab).

FDA approved Cholbam for patients with bile acid disorders due to various single enzyme defects. Two PCSK9 inhibitors approved last year, Praluent and Repatha, are indicated for familial hypercholesterolemia, a genetic disorder that causes high cholesterol levels. The label for Rexulti, a schizophrenia and major depressive disorder drug, recommends dose reductions for "known" poor CYP2D6 metabolizers, as does the label for the schizophrenia drug Aristada.

The agency also approved Nucala last year, a new treatment for asthma patients who experience severe attacks despite treatment. The drug works by reducing levels of eosinophils, a white blood cell involved in the development of asthma, and is indicated for severe asthma patients 12 and older with the eosinophilic phenotype.

Five of the 13 new personalized drug approvals were for oncology indications. Looked at another way, 35 percent of the 14 new cancer drugs approved in 2015 were personalized, according to PMC.

Beyond this, the PMC counted four new molecularly defined indications for previously approved drugs and three new treatments of rare genetic disorders in 2015. "The high proportion of new approvals that are personalized medicines demonstrates the progress researchers have made in advancing the field from an emerging idea a decade ago to an established approach to treating many diseases today," the PMC says in a statement.