Novel Drug Approvals: Innovation in 2015

February 2016, Vol 4, No 2 - The First Word
Donald J. Dietz, RPh, MS

Last year was very busy for the US Food and Drug Administration (FDA), relative to drug approvals. In addition to hundreds of generic approvals, 2015 was a banner year for the number of novel drugs approved.

Increasing Novel Drug Approvals

Novel drugs, innovative products that often serve an unmet medical need, or otherwise help advance patient care and public health, accounted for 45 drug approvals in 2015.1 These drugs were approved as new molecular entities or new therapeutic biologics under New Drug Applications or Biologics License Applications, respectively. This is a strong follow-up to 2014, when there were 41 novel drugs approved, and we appear to be experiencing an upward trend. For comparison, the FDA has averaged 28 novel drug approvals per year from 2006 through 2014.

Keeping Up-to-Date with New Drugs

As a pharmacist, it is important to be aware of new drugs, because we may see prescriptions for these products in our pharmacy practices. Although many of these new approvals are for specialty or orphan drugs with small patient populations that we may not see in our own pharmacies, it is still advisable that we recognize and review new products. You could have patients who obtain their other prescription medications at your pharmacy, and these patients or their caregivers may ask questions about these new products, their administration, dosage, side effects, or drug interactions. I find it useful at the beginning of each year to review the new product approvals from the past year.

The FDA's Center for Drug Evaluation and Research (CDER) publishes an annual summary of novel drugs, and I have found that the latest edition provides an excellent overview of new novel drugs approved in 2015.1 I was particularly surprised to see 16 of the 45 novel drugs approved in 2015 deemed First-in-Class, which was seen as an indication of innovation in the US drug market; First-in-Class drugs often have new mechanisms of action. A decade ago there were fewer product approvals, and many of the approvals seemed to be incremental improvements on existing therapy.

Novel Drugs in 2015

Oncology therapies led the way with 9 new novel drug approvals; 4 products were approved to treat multiple myeloma, and 2 products were approved to treat non–small-cell lung cancer. Twenty-one of the 45 novel drugs approved in 2015 were to treat rare or orphan diseases that impact ≤200,000 patients in the United States.

The 17-page report also focuses on the high level of innovation in 45 drug approvals. This was demonstrated by the following approval categories:

  • Fast Track:
    Fourteen of the 45 novel drugs approved in 2015 were designated by CDER as Fast Track, indicating that they have the potential to address unmet medical needs
  • Breakthrough:
    Ten of the 2015 novel drug approvals were designated as Breakthrough therapies, indicating that the drugs' preliminary clinical evidence demonstrated substantial improvement in ≥1 clinically significant end points over other therapies available. Breakthrough status helps shorten the development time of potential new drugs
  • Priority Review:
    Twenty-four of the novel drugs approved received Priority Review because of their potential to provide significant advances in medical care; these drugs are targeted for a 6-month review versus the standard 10-month review
  • Accelerated Approval:
    Six of the approved novel drugs received an Accelerated Approval, which allows for early approval of a drug that offers a benefit over current treatments for a serious or life-threatening illness; drugs granted accelerated approval must undergo additional testing to confirm that benefit. This process expedites availability of the drug to patients in need.

In summary, 27 of the 45 novel drugs approved in 2015 fell into ≥1 of the above expedited categories, demonstrating the efforts of pharmaceutical manufacturers and the FDA to bring valuable, life-saving medications to market. Twenty-nine of the 45 drug products received approval in the United States before being approved in any other country.


In addition to this annual FDA summary, I usually seek out a continuing education program on new drug approvals this time each year. It serves as a good reinforcement of the information reviewed during the year when each product was approved and introduced to the market. Good summary programs of new drug approvals are usually available online from pharmacy schools, or via your local or state pharmacy association.

Although, all too often, we only hear about the high prices of prescription products, I am excited about the degree of innovation and number of new drug approvals in our country. It is my belief that prescription drug products, at roughly 10% of the overall healthcare expenditure, provide the highest value compared with other categories of healthcare expenditure. As novel drug approvals become more innovative and provide breakthrough care, expect the value of drugs in relation to other healthcare expenditures to rise even more.


  1. US Food and Drug Administration; Center for Drug Evaluation and Research. Novel drugs 2015. Published January 2016. Accessed January 26, 2016.
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