More than half of drugs approved in 2013 were specialty, according to FDA

Newly approved drugs down by 30% from 2012

NEW YORK — The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.

In total, 2013 saw the approval of 27 new drugs, down from 39 in 2012. Of the newly approved drugs, 14 were specialty drugs for serious disease states such as chronic viral infections, cancers, autoimmune diseases and genetic disorders. Meanwhile, two new drugs were approved for chronic obstructive pulmonary disease, and two were approved for Type 2 diabetes. Other new drugs were approved for such conditions as depression, epilepsy, athlete's foot and menopause, among other conditions.

Highlights for the year include Gilead Sciences' Sovaldi (sofosbuvir), part of a new generation of hepatitis C drugs that promises to greatly reduce the time required for treatment, while also carrying a high cost that could prompt pharmacy benefit managers like Express Scripts to start a "price war" in order to keep costs down. Another was Biogen Idec's Tecfidera (dimethyl fumarate), a capsule for multiple sclerosis; according to some analysts, while injectable drugs for MS continue to dominate the market, orally administered drugs have been gaining on them, with Tecfidera in particular seeing a large increase in usage among patients.

Analysts have long forecast that specialty drugs would come to dominate new drug approvals as treatments for conditions like cardiovascular disease and psychiatric disorders become increasingly commoditized due to the growth of generics, which now account for about 84% of all prescriptions dispensed in the United States, according to IMS Health.

While the number of new drugs is a steep drop from 2012, it exceeds the annual total of new drugs approved between 2005 and 2010; in 2007, the FDA only approved 18 new drugs. In a report on the new drug approvals for 2012, the agency noted that despite a higher number of approvals that year and the year before, the number of applications for new drugs received by the agency had not seen a significant or consistent increase. 

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