July-New Medicines
This month, Innovation.org highlights the new medicines and treatments recently approved by the FDA and those currently in development to treat and prevent disease. Click on the links below to read more about newly approved medicines, the R&D process, and recent advances in disease treatment and prevention in different disease areas.
New Drug Approvals in 2010
According to a
report published by The Pharmaceutical Research and Manufacturers of America (PhRMA), 26 new medicines were approved by the U.S. Food and Drug Administration in 2010 for better prevention and treatment of disease. The medicines include 15 drugs (also called new molecular entities or NMEs) six new therapeutic biologics, and five other biologics. The new approvals include the following advances:
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2010 Drug Approval Highlights
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Two new treatments for multiple sclerosis (MS): The first treatment to help improve walking for adults with MS[i] and the first oral drug to reduce relapses and delay disability progression in MS patients.[ii]
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New treatments for prostate cancer: The first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with another standard treatment[iii] and the first cancer immunotherapy for certain men with advanced prostate cancer that stimulates their own immune system to fight the disease. Developed specifically for each patient, the treatment is made by obtaining a patient’s immune cells from the blood using a process known as leukapheresis, then activating the cells to specifically target cancer cells in the patient.[iv]
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New injectable osteoporosis medicine: A first-in-class[v] twice-a-year medicine that works to decrease the destruction of bone and increase bone mass and strength.[vi]
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New treatment to prevent stroke: The first new oral anticoagulant in 50 years indicated to prevent stroke and blood clots in patients with abnormal heart rhythm.[vii]
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Many other drugs and biologics have been approved by the FDA in recent years.
Learn more
New Medicines in Development
Today, over 3,050 medicines are in development for specific disease areas such as cancer, heart disease, stroke, and aging-related diseases.
Cancer
There are few things that cause patients more fear and uncertainty than a cancer diagnosis. Yet today, because of a steady stream of new and improved medicines and treatments, cancer increasingly can be managed and even beaten. Patients and their families are looking for even more and better treatments, and America’s biopharmaceutical research companies are responding. Learn more
Heart Disease and Stroke
Keeping up the momentum of drug discovery that has helped cut deaths from heart disease and stroke in half in the past three decades, biopharmaceutical companies are working on 312 medicines for these diseases. All of the medicines are either in clinical trials or awaiting approval by the Food and Drug Administration. Learn more
Rare Diseases
The National Institutes of Health estimates that there are approximately 6,000 rare diseases affecting 25 million Americans. A rare disease is defined as a condition affecting fewer than 200,000 people in the United States. In the past, treatment options for such conditions have been nonexistent or limited, but approval of several new medicines in this research sector over the last few years has fostered great progress. Learn more
Skin Diseases
There are currently 277 medicines in development to help the more than 100 million Americans, one third of the U.S. population, that suffer from at least one skin disease. Learn more
Women
Medical researchers are making unprecedented progress into understanding why women suffer disproportionately from a number of diseases. Currently, 851 medicines are in development for diseases that disproportionately affect women. Learn more
Other Disease Areas
America’s biopharmaceutical companies are developing thousands of medicines across many other disease areas including Alzheimer’s, HIV/AIDS, diabetes, and mental illness. Learn more
Medicines in Development Database
PhRMA’s medicines in development database contains information about medicines currently in clinical trials or at FDA for review. Learn more
It takes about 10-15 years to develop one new medicine from the time it is discovered to when it is available for treating patients.
Click here to learn more about the many steps in the pharmaceutical research and development process.
Inside Drug DiscoveryThe Researchers behind the Medicines – Discoverers Awards
Each year, PhRMA honors pharmaceutical research scientists whose research and development of new medicines have greatly benefited humankind, and whose dedication and interest in improving the quality of life exemplify the best in the research industry with the Discoverers Award.
Click here for a list of all of the Discoverers Awards given by PhRMA since 1987.
Additional Resources
Patient Assistance Programs
The Partnership for Prescription Assistance serves as a resource to help patients who lack prescription drug coverage get the medicines they need. Lean more
Clinical Trials Resources
Visit our Clinical Trials Resources page to get information about ongoing clinical trials for medicines in development across disease areas in the United States and around the world. Learn more
[i]Food and Drug Administration, "FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis," 22 January 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198463.htm
[ii]Food and Drug Administration, "FDA Approves First Oral Drug to Reduce MS Relapses," 22 September 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226755.htm
[iii]Food and Drug Administration, "FDA Approves New Treatment For Advanced Prostate Cancer," 17 June 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216143.htm
[iv]Food and Drug Administration, "FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer, 29 April 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm
[v]Amgen, " FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture," press release, 1 June 2010, http://www.amgen.com/media/media_pr_detail.jsp?year=
2010&releaseID=1433162
[vi]Food and Drug Administration, "FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women," 1 June 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm214150.htm
[vii]Food and Drug Administration, "FDA Approves Pradaxa to Prevent Stroke in People with Atrial Fibrillation," 19 October 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm
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