Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) sixth annual Novel Drugs Summary.
Each year, CDER approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of already-approved products, or cost-saving generic formulations. These new products contribute to quality of care, greater access to medication, more consumer choice, and a competitive marketplace that enhances affordability and public health. However, a small subset of these new approvals, referred to as novel drugs, are among the more innovative products that often help advance clinical care to another level. At the end of each calendar year, CDER summarizes these new products.
Our annual summary reports the number of novel drugs approved. However, we also focus on the medical value of many of these new drugs, their contributions to enhanced patient care, and the various regulatory tools CDER used to help ensure their safe and efficient development and approval. In 2016, novel approvals include the first treatment for patients with spinal muscular atrophy, the first drug approved to treat Duchenne muscular dystrophy, a new drug to treat hallucinations and delusions in some people with Parkinson’s disease, a new drug to treat patients with a rare chronic liver disease known as primary biliary cirrhosis, and two new treatments for patients with hepatitis C. The field also includes new treatments for patients with ovarian cancer, bladder cancer, soft tissue sarcoma, and chronic lymphocytic leukemia—as well as two new diagnostic agents for detecting certain forms of cancer.
All of these newly approved products were required to meet our rigorous premarket safety standards—and they will all be part of a strong postmarket safety surveillance system watching how they perform after they are more widely used by larger patient populations. Complementing this year’s summary of novel approvals is CDER’s recent report titled, Drug Safety Priorities 2015-2016, which details the Center’s key safety priorities as well as the depth and versatility of drug safety initiatives across CDER and the FDA. The report includes program updates and milestones achieved since the start of 2015, describing a variety of the FDA’s most important efforts in drug safety science, surveillance, and oversight.
We hope our Novel Drugs summary provides an appreciation of the expected impact that many of the novel drug approvals of 2016 will have on patient care, as well as the valuable role CDER played in helping to bring these drugs to market.
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
CDER’s 2016 Novel Drug Approvals
22 novel drugs
In calendar year 2016, FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel drugs, approved either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). Listed below are CDER’s novel drugs of 2016.*
Novel drugs are often innovative products that serve previously unmet medical needs or otherwise significantly help to advance patient care and public health. NMEs have chemical structures that have never been approved before. However, in some cases an NME may have actions similar to earlier drugs and may not necessarily offer unique clinical advantages over existing therapies. This report summarizes all of the 2016 NME and novel BLA approvals, emphasizing those that offer new and innovative treatments to patients in need.
The vertical bars in the graph below indicate the number of novel drugs approved by CDER in each year of the past decade. CDER approved 22 novel drugs in 2016. From 2007 through 2015, CDER has averaged about 30 novel drug approvals per year.
Applications for new approvals remain steady
CDER approved a lower than average number of novel drugs in 2016, but the number of applications for these drugs that sponsors have submitted over time has remained relatively stable.
The points connected by lines in the graph below indicate the number of new NDA and BLA applications for NMEs and new the...
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