FDA Approved 88 New Medicines: PharmaLive Special Report
FDA approved 88 new medicines in 2010, dropping slightly compared to 92 in 2009. New molecular entity (NME) approvals also declined in 2010 to 21, down from 26 in 2009. However, 14 less new drug applications for NMEs were submitted during 2010 versus 2009. These newly approved drugs treat a variety of conditions including asthma, humoral immunodeficiency, multiple sclerosis, postmenopausal osteoporosis, rheumatoid arthritis, and schizophrenia.
Among the highly anticipated new medicines approved in 2010 are first-in-class drugs Gilenya, developed by Novartis, and Provenge, developed by Dendreon. Gilenya is the first oral drug approved to treat relapsing forms of multiple sclerosis in adults. Provenge is designed to use the patient's own cells to stimulate the body's immune system.
As patent protection expires for a number of billion-dollar brands and new medicines are slow to reach FDA approval due to stringent safety issues, the annual total of blockbuster products could be on the decline. However, megabrand potential still exists for new drug compounds to enter the marketplace in therapeutic areas such as atherosclerosis, cancer, and diabetes.
"Biologics accounted for a significant amount of FDA's new drug approvals during 2010," says Andrew Humphreys, editor in chief of UBM Canon Data Products. "Some of these biologics are projected to become blockbuster brands, such as Prolia/Xgeva for osteoporosis and skeletal-related events from solid tumors; Actemra for rheumatoid arthritis; the blood thinner Pradaxa; the oral multiple-sclerosis drug Gilenya; and the prostate-cancer vaccine Provenge."
Amgen's denosumab, which was FDA-cleared under two different brand names, is the most talked about NME approval of 2010. Denosumab was initially approved in June as Prolia, a first-in-class drug for testing postmenopausal osteoporosis. Prolia is expected to attain blockbuster sales status while billion-dollar osteoporosis brands such as Fosamax, Boniva, and Actonel lose patent protection.
Denosumab was additionally approved by FDA under the brand name Xgeva in November. Xgeva is indicated in the United States for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Xgeva represents the first new treatment in almost a decade for advanced cancer patients with bone metastases to prevent skeletal-related events.
More information is available in New Drug Review and Outlook 2011, available at www.pharmalive.com/specialreports <http://www.pharmalive.com/specialreports>
For additional information, contact Sandra Baker at +1-215-944-9836 or Sandra.Baker@ubm.com.
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