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Improving the Lives of

Improving the Lives of Patients In recent years, many new treatment options have emerged that are having a profound impact on the lives of patients. Many of these advances transform what were once considered fatal illnesses into manageable conditions and, in some cases, may even cure a disease. Often new medicines fill an important unmet need or provide an effective alternative where there previously were none. Many recent advances also facilitate adherence to treatment, halt disease progression, and help prevent serious complications, thus enabling patients to live longer, healthier lives. Last year was an exceptionally strong year for biopharmaceutical innovation. The US Food and Drug Administration (FDA) approved 56 new medicines, including 45 new medicines approved by the Center for Drug Evaluation and Research (CDER)—the highest number of approvals in almost two decades, giving patients even greater hope for the future (see Figure 1). 1,2 2 Improving the Lives of Patients

Among CDER’s approvals, 36% were first-in-class medicines, representing entirely new ways of treating disease. 3 This incredible progress reflects a harnessing of scientific breakthroughs and our improved understanding of today’s most complex and challenging diseases. In 2015, novel therapies were approved across a broad range of disease areas. A few examples of important new treatment options brought to patients this year include: Advanced Melanoma: Two new medicines for the treatment of melanoma—the most aggressive and deadly form of skin cancer—became available to patients. One of these treatments, a personalized medicine approved for use in combination with another targeted therapy, prevents and slows cancer cell growth in melanoma patients who have a specific genetic abnormality. The other medicine is the first FDA-approved oncolytic virus therapy. This medicine uses a genetically modified herpes virus and is injected directly into FIGURE 1: FDA Approved Medicines* 60 53 50 45 40 39 35 36 39 41 30 20 22 30 20 30 28 26 25 21 21 22 23 22 30 27 24 17 21 20 22 18 24 26 21 30 27 27 28 14 10 12 0 1980 1985 1990 1995 2000 2005 2010 2015 *Medicines approved by the FDA's Center for Drug Evaluation and Research (CDER). Sources: US Food and Drug Administration. Summary of NDA approvals and receipts, 1938 to the present. http://www.fda.gov/aboutfda/whatwedo/history/productregulation/ summaryofndaapprovalsreceipts1938tothepresent/default.htm. Published January 18, 2013. Accessed March 2016; US Food and Drug Administration. New drugs at FDA: CDER’s new molecular entities and new therapeutic biological products. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm20025676.htm. Updated February 8, 2016. Accessed March 2016. Improving the Lives of Patients 3

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