FDA CDER Novel Biologic Drug Approvals 2016

The FDA released its report titled “Novel New Drugs 2016 Summary,” in which they discuss 2016 FDA new drug approvals. In 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel new medicines. The number of approvals in 2016 was down from 2015 with 45 approvals and down from 2014 with 41 approvals. In fact, in looking at approvals over the past five years, 2016 had the lowest number of approvals overall, however the number of new drug filings remained consistent.

Other highlights from the report include:

  • 8 of the 22 novel drugs were considered “first in class” which means that they utilize a novel or unique mechanism of action over existing therapies.
  • 9 of the 22 NMEs were approved to treat orphan diseases. Orphan diseases are considered rare diseases that affect 200,000 or fewer Americans.
  • 16 of the 22 NMEs were designated in one or more expedited pathway categories – Fast Track, Breakthrough, Priority Review, and Accelerated Approval

Fast Track designation is identified by FDA as drugs with the potential to address unmet medical needs. “Fast Track speeds new drug development and review, for instance, by increasing the level of communication FDA allocates to developers and by enabling developers to use a “rolling review” process such that CDER can review portions of an application ahead of the submission of the full application.” (8 novel drugs had this designation)

Breakthrough designation is identified by FDA as drugs with preliminary clinical evidence that shows the potential of substantial improvement over at least one clinically significant endpoint compared with current therapy. “A breakthrough therapy designation conveys all of the fast track program features as well as more intensive FDA guidance on an efficient drug development program.” (7 novel drugs had this designation)

Priority Review is determined by FDA that the drug has the potential to provide a significant advance on medical care. With priority review, FDA sets a target to review the drug within six months instead of the standard that is 10 months. (15 novel drugs had this designation)

Accelerated Approval allows early approval of a drug for a serious or life-threatening illness that offers benefits over current treatments. “This approval is based on a “surrogate endpoint” (e.g., a laboratory measure) or other clinical measure that FDA considers reasonable likely to predict clinical benefit. After this approval, the drug must undergo additional testing to confirm that benefit; this speeds the availability of the drug.” (6 novel drugs had this designation)

  • 21 of the 22 were approved on the first cycle, which means that they were approved without the need for additional information that would delay approval.
  • 19 of the 22 were approved first in the United States before any other country.

Novel Biologic Drugs Approved by CDER in 2016

Included in the report were 7 biotech drugs or biologics that were approved by CDER. This number was down from last year where there were 13 approved. In addition, 5 of the 7 approved biologics participated in at least one expedited pathway designation.

Table 1: Biologics approved by FDA (CDER) in 2016, in order of approval date (latest to earliest)
Drug Name Active Ingredients FDA Expedited Pathway Expression System Company Indications
Zinplava bezlotoxumab First in Class, Fast Track, Priority Review Not provided Merck
To reduce the recurrence of Clostridium difficile
infection in patients aged 18 years or older
Orphan, Fast Track, Priority Review, Accelerated Approval Olaratumab is a recombinant human IgG1 monoclonal blocking antibody that binds specifically to human platelet-derived growth factor receptor alpha (PDGFR-α) produced in genetically engineered mammalian NS0 cells. Eli Lilly and Company
To treat adults with certain types of soft tissue
Zinbryta daclizumab First in class Not provided Biogen and AbbVie
To treat multiple sclerosis
Tecentriq atezolizumab Breakthrough, Priority Review, Accelerated Approval Not provided Genentech
To treat urothelial carcinoma, the most common
type of bladder cancer
Cinqair reslizumab n/a CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal anti-body (IgG4k). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Teva Respiratory To treat severe asthma
Taltz ixekizumab n/a Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Eli Lilly and Company
To treat adults with moderate-to-severe plaque
Anthim obiltoxaximab Orphan, Fast Track Not provided Elusys Therapeutics
To treat inhalational anthrax in combination
with appropriate antibacterial drugs.
Source: FDA and Prescribing Information

For the previous year’s coverage, please see:

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