By: John K. Jenkins, M.D.
Happy New Year! Looking back at 2015, I’m pleased to report another strong year for FDA approvals of novel new drugs, which offer many patients new treatment options for serious and life-threatening conditions. In 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel new therapies – significantly more than the average of 28 we have approved during the previous nine years of this decade.
But far more important than quantity is quality – and the valuable new roles many of these drugs can serve in advancing medical care and the health of patients. During this past year, we approved many new drugs to treat various forms of cancer, including four to treat multiple myeloma, and others to treat lung, skin, breast, brain, colorectal, and other cancers. We also approved new drugs to treat heart failure, high cholesterol, cystic fibrosis, and irritable bowel syndrome, as well as the first approved reversal agent for a commonly-used blood thinner. And, for the second consecutive year, we approved more drugs to treat rare diseases than any previous year in our history.
Here are a few highlights of these approvals:
- More than one-third of the novel new drugs CDER approved in 2015 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;
- More than 40% of these new therapies were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans–Americans who often have few or no drug treatment options;
- 60% of CDER’s novel new approvals for 2015 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; and
- 64% of CDER’s novel new approvals were approved first in the United States before any other country.
For more details about 2015’s approvals, please visit the Novel New Drugs Summary 2015.
As always, compromises were not made in our review standards as we considered the applications as efficiently as possible. In short, each of these therapies had to demonstrate that it was safe and effective before being approved. I am pleased and proud to be part of a team that helped bring these new drugs to market as safely as possible. My colleagues and I look forward to another productive year serving the American public!
John Jenkins, M.D., is Director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research