FDA approved 45 new drugs in 2015--a new recent record

January 4, 2016
Pharmaceutical Commerce, Pharmaceutical Commerce - January/February 2016,

List includes 21 new orphan drugs, and of the 45, 15 are cold chain products

It’s a great way to start the New Year: FDA’s Center for Drug Evaluation and Research (CDER) reports 45 “novel new drugs” were approved in 2015, up from 2014’s 41, and representing a new high not seen since the mid-1990s. The drug-approvals count is fraught with conflicting perspectives: some feel that FDA puts too many obstacles in front of approvals; and some are concerned that the more streamlined orphan-drug pathway is being abused. Nevertheless, FDA uses the occasion for some chest-thumping: nearly two-thirds of the approvals (29 of the 45) were first-in-the-world.

“More important than the quantity of novel new drugs approved in 2015 are the qualities of the new drugs the pharmaceutical industry has developed and the important new roles these drugs are serving to advance medical care,” said John Jenkins, director of the Office of New Drugs in CDER. “Also noteworthy is the efficiency with which most of these drugs were reviewed and approved. CDER used a variety of expedited development and review regulatory tools in an effort to help speed these drugs to market.”

Some highlights:

  • More than one-third of the novel new drugs CDER approved in 2015 were identified by FDA as “first-in-class,” for example, drugs that use a new and unique mechanism of action for treating a medical condition
  • More than 40% of these new therapies were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans. Peter Saltonstall, head of the National Organization for Rare Disorders (NORD), noted in a statement that the total of orphan approvals “underscores the progress we are making in identifying and studying new therapies, the willingness of the investment community to invest in orphan drugs, and the continued flexibility shown by the FDA in reviewing applications that often include small studies due to the small number of patients with the disease.”
  • 60% of CDER’s novel new approvals for 2015 were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval.
  • In 2015, CDER met its PDUFA goal dates for 96% of the novel new drugs approved (43 of 45). PDUFA (Prescription Drug User Fee Act) dates are agreed to between FDA and the drug sponsor, and represent a commitment for timely review of an application by FDA.

For those concerned with the safe storage and transportation of drugs, it’s worth noting that 15 of the 45 approvals are for cold chain products, usually requiring refrigerated (2-8°C) conditions. Pharmaceutical Commerce, in its annual Biopharma Cold Chain Sourcebook, notes that the dollar volume of cold chain products is growing at twice the rate of all pharma products. A 2015 approvals list from the Center for Biologics Evaluation and Research CBER) includes 12 new drugs (derived from blood products) and vaccines; of those, 11 require cold chain handling.