Personalized Medicine Coalition Applauds FDA Move

The Personalized Medicine Coalition (PMC) announces its appreciation of the U.S. Food and Drug Administration’s (FDA) decision to expand the black box warning on abacavir, a drug used to treat HIV infection.

The new label recommends that all patients undergo screening for the HLA-B*5701 allele before starting or restarting an abacavir-containing regimen in keeping with a larger trend towards personalized medicine.

Personalized medicine represents a shift from the traditional one-size-fits-all approach in therapeutic selection to one that is individually tailored based on molecular diagnostics. By tying dosing and therapeutic selection decisions to a diagnostic test, which is often genetically-based, personalized medicine can deliver higher-quality care that is safer and more efficacious.

“This is a step toward the future that we’re working for – when we can use our personal genetic information to know whether a drug will be effective for us, or dangerous for us – before it is taken,” according to Dr. Gregory Downing, Director, Personalized Health Care Initiative, U.S. Department of Health and Human Services. “It is a harbinger of safer, more effective medical care through pharmacogenomics,” he concluded.

Between 5-8% of patients carry the HLA-B*5701 allele, which puts them at a 60% risk for experiencing a severe adverse reaction to abacavir, while patients without the marker have about a 4% risk.

FDA’s announcement follows its decision last year, through a label change, to recommend genetic testing to inform dosing decisions for the widely prescribed blood-thinning drug warfarin.

The PMC applauds the Agency’s continuing focus on improving the safety and effectiveness of drugs by incorporating, where possible, the principles of personalized medicine.