2011: A Year of Important Pharmacological Advances for Patients

2011: A Year of Important Pharmacological Advances for Patients
December 21, 2011
http://www.innovation.org/index.cfm/NewsCenter/Newsletters?NID=193

New advances in biopharmaceuticals came as welcome good news for U.S. patients. In recent years, despite increasing investments in R&D, fewer medicines have recieved approval, reminding us just how difficult drug discovery is. But in 2011 there were more new medicines approved than in recent years and these approvals represented important advances in many areas.

The Food and Drug Administration reported in November that in fiscal year 2011 (10/1/10–9/30/11) there were 35 new medicines approved,[i] among the highest in the last decade. According to the FDA report, "few years have seen as many important advances for patients." The final tally of medicines approved in calendar year 2011 waits to be seen but it is clear that 2011 has been a great year for advancing the fight on many disease fronts. Below is information on some of the treatments highlighted in the FDA report.

Cancer: With improvements in early detection and a steady stream of new and enhanced treatments cancer can be more effectively managed and even beaten. Two new personalized medicines for lung cancer and melanoma now provide effective options for patients with tumors expressing certain genetic markers.[ii] The personalized melanoma treatment and another new melanoma medicine became the first new approvals for the disease in 13 years. Read about continued efforts to improve cancer treatment and the 887 medicines currently in development.

Rare Diseases: An estimated 25-30 million Americans suffer from rare or "orphan" diseases, which are often among the most devastating to patients and complex for researchers.[iii] However, advances in science have allowed us to hone in on the causes of many rare diseases and translate those findings into new treatments. Between January 1st and December 7th 2011, eleven new medicines to treat rare diseases were made available to patients for diseases such as the genetic defect congenital Factor XIII deficiency, several cancers, and scorpion poisoning.[iv] A record 460 new medicines are in clinical trials or awaiting FDA review.[v] Read more about the ongoing commitment to improve treatment for rare diseases.

Lupus: Lupus is a serious and potentially fatal autoimmune disease that attacks healthy organs and tissues of the body. For the approximately 300,000 to 1.5 million lupus sufferers in the U.S. the last approved drug came in 1955. This year a newly approved medicine ended that drought with a new approach to treating lupus. Read more about medicines in development for autoimmune diseases.

Hepatitis C: Hepatitis C is a chronic viral disease that affects the liver and can lead liver cancer and liver failure. It affects approximately 3 million people in the United States. Two new medicines approved this year are the first in a new class and offer a greater chance of cure for some patients compared with existing therapies. For more information on medicines in development for infectious diseases, click here.

This is only a partial list of the many advances approved in 2011, for a more complete listing visit www.FDA.org.

Looking ahead to 2012, biomedical research continues to draw us in new directions and helps us to better understand the cause and progression of disease. Coupled with innovative approaches at the bench and in the clinic, we can better prevent, detect, and treat disease to save and improve lives.


References
[i]US Food and Drug Administration, FY2011 Innovative Drug Approvals, (November 2011) http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm

[ii]US Food and Drug Administration, FY2011 Innovative Drug Approvals, (November 2011) http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm

[iii]PhRMA, Orphan Drugs in Development for Rare Diseases (February 2011) http://www.phrma.org/sites/default/files/878/rarediseases2011.pdf

[iv]US Food and Drug Administration, CDER New Drug Review: 2011 Update (December 2011) http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM282984.pdf

[v]PhRMA, Orphan Drugs in Development for Rare Diseases (February 2011) http://www.phrma.org/sites/default/files/878/rarediseases2011.pdf