Another Strong Year for Novel New Drug Approvals

By: John K. Jenkins, M.D.

Last year marked another strong year for FDA approvals of novel new drugs, known as new molecular entities (NMEs).  In 2013, FDA’s Center for Drug Evaluation and Research (CDER) approved 27 NMEs last year – about the same as the 26 average NME approvals per year since the beginning of this decade.

John JenkinsMore important than the quantity of novel new drugs approved in 2013 is their quality – and the important new roles many of these drugs can serve in advancing medical care and the health of patients. We now have new safe and effective treatments for a wide range of serious medical conditions, such as late-stage breast cancer, chronic hepatitis C, metastatic melanoma, mantle cell lymphoma, chronic lymphocytic leukemia, homozygous familial hypercholesterolemia, pulmonary arterial hypertension, and many more. Some of these medications offer new hope to patients who previously had few or no treatment options.

Here are a few highlights of these approvals:

  • One-third of the NMEs approved in 2013 were identified by FDA as “first-in-class,” for example, drugs that use a new and unique mechanism of action for treating a medical condition;
  • One-third were also approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans who often have few or no drug treatment options;
  • Almost half of the 27 NMEs approved last year (13 of 27), were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval. Each of these designations helps speed the development and/or approval process and is designed to help bring important medications to the market as quickly as possible;
  • Although FDA’s regulatory processes differ widely from those of foreign regulatory authorities, almost three-quarters (74%) of the NMEs approved by FDA in 2013 were approved first in the United States before any other country.

All of us at FDA are pleased and proud to be part of a team that helped bring these new drugs to market as safely and efficiently as possible. As always, while striving for efficiency in our review and approval of applications for new drugs, compromises were not made in our standards. To be approved, each NME had to demonstrate that it was safe and effective before being approved.

My colleagues and I look forward to another productive year serving the American public!

For more details about 2013’s approvals, please visit The Novel New Drugs Summary at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf

John K. Jenkins, M.D., is Director, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research

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