Record Number of Personalized Medicines Approved in 2018
February 13, 2019 – Forty percent of the new drugs approved by the U.S. FDA in 2018 are personalized medicines, according to a report from the Personalized Medicine Coalition (PMC). Out of 59 approvals for novel drugs, 25 were for drugs that offer targeted treatment based on individual patient factors such as the presence of key biomarkers.
The report, which is available for download online, indicates that 2018 is the second year in a row where more than 30% of the FDA’s novel drug approvals were personalized medicines. Approved indications included treatments for cancer, HIV infection, malaria, and genetic disorders such as cystic fibrosis and Fabry disease.
Launched in 2004, the Personalized Medicine Coalition advocates for the adoption of personalized medicine in the United States. Doctors practicing this type of medicine use diagnostic tests to determine the most effective treatment available for each individual patient. This is a departure from medical practices that treat disease using a “one-size-fits-all” approach. Such approaches can fail to account for individual patient differences such as genetic contributors to disease that may affect treatment success.