FDA Clears 41 New Drugs in 2014; Approval Rate Hits 18-Year High

The number of U.S. drug approvals in 2014 reached the highest level since 1996, primarily driven by cancer drugs and treatments for rare diseases, Reuters reports.

Specifically, FDA approved 41 new medicines in 2014, up from 27 in 2013. According to Reuters, treatments for rare diseases comprised almost 40% of FDA's 2014 approvals. However, insurers and governments have started to push back against the high costs of some of these new drugs, such as AbbVie's new hepatitis C treatment.

Drug approval "highlights" include Merck's Keytruda and Bristol-Myers Squibb's Opdivo, novel cancer treatments that provide long-lasting treatment with fewer side effects. Analysts have suggested that such drugs mark the start of a wave of immunotherapies that could yield more than $30 billion annually in sales.

According to Reuters, the surge in new approvals helped biotech initial public offerings hit record highs last year. The Nasdaq Biotechnology Index rose by 34%, while the S&P 500 Health Care Index rose by 23% (Hirschler, Reuters, 1/1).