World Literature

Of course it is more than a roll of the dice. A lot of work and effort goes into medical treatment applications for approval and into evaluating them for consideration. As was widely discussed in FDA-watching circles, the agency approved a total of 41 novel new drugs in 2014 – the most in a decade. Novel new drugs are are a subset of the overall number of new product approvals and often represent those drugs which offer an advancement in patient care and public health in some way.

In January FDA published a report – Novel New Drugs 2014 Summary – that provides a very comprehensive overview profiling the new drugs approved in 2014. Here are the highlights:

• Over the past decade, the number of novel new drugs approved each year was 25. This year FDA approved 41 – if I’m not mistaken that would be a 64 percent increase over the average;
• 17 (41 percent) of the 41 NMEs approved were first-in-class drugs;
• 17 (41 percent) were for rare diseases;
• There were 4 new approvals for Type 2 diabetes and 3 for acute bacterial skin structure infections
• 17 of the drugs were on FDA’s Fast Track
• 9 were given Breakthrough status
• 25 of the drugs had Priority Review
• 8 of the new approvals were under Accelerated Approval (note that these classifications are not mutually exclusive and a drug could have been given more then one of these designations – for a definition of each, see here)
• The agency met PDUFA dates in 40 of the 41 NME approvals (98 percent)
• 26 (63 percent) of the drugs were first approved in the U.S.

In the report, FDA provides an overview chart for each drug that ticks off the various characteristics of its approval and even lists the dosage form. In addition, there is further more detailed information about the approvals.

Overall, a banner year for the agency with respect to NMEs – one that may be tough to beat. So far January has seen several approvals for drugs and one for a novel device to treat obesity. We’ll keep our eye on it.