A Year in Review: FDA 2015 New Drug Approvals

The approval of first-of-a-kind drugs rose last year to forty-one, resulting in the highest level of newly approved U.S. drugs in nineteen years. The total number of new drugs approved last year was even higher at sixty-nine. The rising figures reflect an industry-wide desire to research and develop drugs for rare and hard-to-treat diseases.

The newly approved drugs serve to advance medical care and the health of patients suffering from many ailments, including various forms of cancer, heart failure, and cystic fibrosis. Additionally, more than 40% of the new therapies were approved for treatment of rare or “orphan” diseases that affect less than 200,000 Americans. Those suffering from orphan diseases often have few or no drug treatment options; these approvals will provide great help to their treatment regimen.

This trend of increasing numbers of new drugs is beneficial for both industry and patients. Between 2007 and 2011, only one in nineteen drugs that entered early-stage testing made it to market, compared to one in thirteen drugs today. While more drugs may be making it to market, the development time for drugs is increasing, likely due to the complexity of drug trials and demands for more data from health insurers. However, for 2015 new drug approvals, 60% were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval. A therapy with one of those designations is helped along the process at a more rapid pace.

Below is a chart of all sixty-nine drugs that were approved in 2015, and their indication. Novel new drugs’ brand names are bolded.