FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
NEW YORK, NY -- (Marketwire) -- 03/11/13 -- Programs developed by the U.S. Food and Drug Administration to speed up the approval process has been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year high of 39, over the past decade drug approvals has averaged roughly 23 a year, according to a recent Bloomberg article. Five Star Equities examines the outlook for companies in the Biotechnology Industry and provides equity research on Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) and Peregrine Pharmaceuticals
. The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA'sCenter for Drug Evaluation and Research.
Peregrine Pharmaceuticals patented monoclonal antibodies target various physical structures common to tumors or infected cells as a means to selectively target therapy and diagnostics, while sparing normal, healthy cells. Their most advanced research focus is on the development of therapeutic antibodies that specifically target and act upon features of cancer and viral infections, including the blood vessels feeding tumors, distinctive features in the central core of tumors and cells that have been infected with viruses.