Research and Markets: New Drug Review and Outlook 2011 - Report Available Now

DUBLIN--(BUSINESS WIRE)-- Research and Markets ( has announced the addition of the "New Drug Review and Outlook 2011" report to their offering.

The U.S. Food and Drug Administration 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. 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.

New Drug Review and Outlook 2011 is presented in the following four sections.

  • Potential Blockbusters
  • Products Awaiting FDA Clearance
  • FDA's New Medicines of 2010
  • U.S. Approvals Over Time

What you will find in this special report:

In the first part, analysis is provided regarding some of the most-anticipated products expected to emerge from the late stages of the industry pipeline. The second segment presents a listing of new drugs awaiting first-time FDA approval. The report's third portion contains an overview of the 88 new prescription medicines that were approved via a new drug application (NDA) or biologic license application (BLA) in the United States during 2010. The fourth sector of this report lists in alphabetical order the products that have been approved by FDA via an NDA or BLA since 1990.

Key Topics Covered:

  • Select Potential Blockbusters in the Pipeline
  • Prescription Products Awaiting FDA Approval
  • FDA's New Medicine Approvals of 2010
  • FDA's New Molecular Entity Approvals of 2010
  • Best New Medicine of 2010
  • FDA New Drug Approvals: 1990-2010

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Research and Markets
Laura Wood, Senior Manager,
[email protected]
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Fax (outside U.S.): +353-1-481-1716

KEYWORDS:   United States  North America

INDUSTRY KEYWORDS:   Health  Pharmaceutical  Research  Science