FDA Approves Record-Breaking 59 Novel Drugs in 2018

The past year proved to be a big one for the U.S. Food and Drug Administration (FDA) and the approval of novel drugs. Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more. Over the past 190 years, the FDA has averaged an approval of 33 novel drugs each year, with 2018 having the highest number. In 2017, the FDA approved 46 novel drugs, but only 22 in 2016.
Novel drugs are classified as new molecular entities. In its classification, the FDA said: “many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product.” In a report issued on its drug approvals for 2019, the FDA noted that many of the novel drugs approved over the past year were notable due to their “positive impact and unique contributions to quality medical care and patient treatment.” Of the 59 novel drugs approved in 2018, 19 of them, 32 percent, were considered first-in-class. The FDA noted that this designation is a strong indicator of a drug’s potential positive impact on healthcare. Novel drugs approved in 2018 that FDA identified as first-in-class include Aimovig, Galafold, and Vitrakvi.