New drug approvals slump as early wins, CRLs hit rates

2016's tally will not come close to record NME approval levels in 2014 and 2015

Record approvals of new drugs in 2014 and 2015 won't be repeated this year, but the number of filings is still at a very high level. So what is going on?

John Jenkins, who is retiring as director of the FDA's Center for Drug Evaluation and Research (CDER) next year, said that the agency received 36 NME applications, just above the average of 35 filings in recent years.

Jenkins said approvals of new molecular entities (NMES)—based on compounds that have never been cleared for marketing before—are currently running at 19 this year, although his remarks came ahead of the green light for Pfizer's atopic dermatitis drug Eucrisa.  


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While there is traditionally a last-minute rush for approvals, this year's tally isn't going to come close to the 45 NMEs approved in 2015, and 41 in the prior year. The number of novel drugs and biologics under active review at the FDA is also down on 2015 and roughly in line with 2014.

The explanation? Five drugs scheduled for approval in 2016 ended up getting the go-ahead in the previous year, said Jenkins, and there was also a sizeable increase in applications that resulted in a complete response letter (CRL), in other words they were batted back for not hitting the mark for approval. There have been 12 CRLs so far in 2016, compared to just two in 2015.

One possible explanation for the hike in CRLs could be that greater use of speedier approval pathways designed to accelerate access to new medicines is raising the risk of failure at the first hurdle. The number of applications of given some form of quick review increased again in 2016, hitting 68% of the total compared to 60% last year, while a third had been given breakthrough designations.

Jenkins ran through the numbers as Deloitte's new report on pharma R&D productivity painted a similarly depressing picture for the industry, suggesting that returns on R&D spend among large and mid-sized companies are continuing to decline.

On the upside, Jenkins said it was encouraging that so many of the new approvals in 2016 are innovative medicines. More than a third are indicated for rare diseases, 37% are first-in-class drugs and eight out of 10 have been cleared in the US ahead of other markets.

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