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Regulatory News | 11 December 2014 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals."
"With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013," said FDA Commissioner Margaret Hamburg in a posting on the agency's FDA Voice blog.
The agency said the 35 drugs included new molecular entities (NMEs) and new therapeutic biologics, both of which are approved by CDER.
Hamburg noted 15 of the 35 approvals were for so-called "rare" diseases affecting fewer than 200,000 patients in the US—the highest number of rare disease drugs it has ever approved in a single year.
Hamburg said several of the agency's approvals this year were especially noteworthy. Its approval of Amgen's Blincyto, for example, came in a full five months ahead of schedule, she noted. The agency also managed to approve three new antibacterial products—Dalvance, Sivextro and Orbactiv—which she said was a "welcome but modest increase in activity in this product area." Between 2004 and 2013, just five new antibacterial products were approved by FDA, she explained.
In a separate presentation posted on FDA's website, CDER's director of the Office of New Drugs, John Jenkins, said seven of the 35 new drugs were also approved after receiving FDA's breakthrough therapy designation.
Just one of the 35 drugs—Akynzeo—did not meet its Prescription Drug User Fee Act (PDUFA) date, Jenkins' data showed. 74% of drugs were approved during their first review cycle, and 57% of drugs were approved under priority review, allowing them to be approved in less than six months instead of the usual 10. An additional 37% of drugs approved were given fast-track designation, giving them additional review resources.
2014 was also a banner year for biologic approvals, in particular. Of FDA's 35 new drugs, 10 were biologics—by far its best year going back to at least 1986. FDA's previous best approval record was six biologics, which it has tied seven times (1996, 2002, 2003, 2009, 2010, 2011, 2012).
Some of the nuances of the metrics aren't explained in Hamburg's announcement, however. In October 2014, FDA made a small but important change to the way it decides what is actually a "new drug" capable of receiving five years of market exclusivity.
Under the change, fixed-dose combination (FDC) drugs consisting of at least one new drug product will be considered by FDA to be "new" drugs. Previously, those products were considered to be old, and subject to lesser periods of new market exclusivity.
The change allowed two FDCs— Gilead's Harvoni (ledipasvir and sofosbuvir) and Eisai's Akynzeo (netupitant and palonosetron)—to be considered new drugs and be counted among FDA's NME tally for the year.
Read all about FDA's new chemical entity exclusivity change here.
Even still, FDA's approval numbers are good news for an agency that has faced pressure over the number of new drugs it has approved in recent years, which peaked at 53 approvals in 1996 and has since varied wildly.
* Applications are often approved in different calendar years than when they are received.
**Tentative. Numbers subject to change and not factored into average.
For more data on FDA's drug approvals, please see our story on the history of drug approvals.
Assuming FDA approves no more applications in 2014, its approval record would be its second-best of the last decade, behind only the 39 NMEs it approved in 2012. It's worth noting, however, that FDA generally approves one or more drugs in the waning days of each year. In 2013, it approved the COPD drug Anoro Ellipta on 18 December, and in 2012 it approved a whopping eight drugs between 14-31 December. According to Jenkins, FDA has 35 NME applications in its possession right now, though it's not clear now many—if any—will be approved in the next 20 days.
FDA's data also revealed the agency is staying ahead of its European counterpart, the European Medicines Agency (EMA), in terms of approvals. Of all drugs approved by FDA, 66% were approved first in the US, Jenkins said. That's down slightly from 2013, when FDA said it approved 74% of NMEs before anyone else.
Jenkins Presentation on Drug Approvals
FDA Voice blog
Tags: FDA New Drug Approvals, 2014 New Drug Approvals, FDA NME Approvals