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 the 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.
Khushboo Sharma, the acting chief of staff at the Office of New Drugs, sees these metrics as evidence that 2018 is a standout year in terms of quality and quantity. Presenting the data (PDF) at the FDA/CMS Summit earlier this week, Sharma picked out GW Pharmaceuticals’ Epidiolex, Johnson & Johnson’s Erleada and other drugs as examples of the quality of this year’s approvals.
The question now is whether 2018, like 1996 before it, is something of an outlier, or if the level of drug development and approval activity has moved up a notch. One way to try to answer that question is to look at the pipeline. That approach yields some encouraging signs for the sustainability of the activity seen this year.
In 2018, there were 7,201 INDs on the FDA’s books. That represents a 3% increase over the previous year, and a 25% jump compared to a decade ago. If the success rate in clinical development remains constant, the level of R&D activity seen in 2018 may translate into more busy years for the FDA’s drug application review teams down the line.