FDA hails 2018 as bumper year for drug development successes

The FDA has hailed 2018 as a standout year for drug development and approvals, both in terms of the quantity and quality of activity. With the FDA approving 55 new molecular entities (NMEs) over the first 11 months of the year, 2018 has eased past 1996 to become the busiest year ever. Perhaps more importantly, the FDA thinks there are plenty of important drugs in the class of 2018. For more than 20 years, 1996 has stood out as the high watermark for drug approvals. Now, there is a new peak on the chart of FDA approvals: 2018. The total for this year has edged past the 53 FDA approvals from 1996, a year when the new user fee program led to a processing of a backlog of submissions that artificially inflated the number. Without the benefit of such a tailwind, 2018 cleared that long-standing high point. The class of 2018 is notable in other regards, too. This year marks the first time that more than half the approved NMEs target orphan indications. One-third of the drugs were first-in-class molecules. Three-quarters of the NMEs benefited from priority review. One-quarter of the approved drugs had breakthrough designations.