2015 was a banner year for novel drugs approved. There were 45 novel drugs approved as new molecular entities (NME) under New Drug Applications (NDAs) or Biologics License Applications (BLAs) in 2015, up from 41 novel drugs approved in 2014. As a comparison, the FDA has averaged 28 novel drug approvals per year in the 2006 to 2014 timeframe.

Pharmacists and healthcare providers should be aware of new drugs that may be seen in practice. While many of these new approvals are for specialty drugs or orphan drugs with a small patient population that may not be seen in a pharmacy, it is still advisable to recognize and review new products. Questions may arise from patients or caregivers regarding these new products, their administration, dosage, side effects or drug interactions.

The FDA’s Center for Drug Evaluation and Research (CDER) publishes an annual summary of novel drugs, which is an excellent source for newly approved novel drugs. Oncology products led the way with nine newly approved novel drugs. Twenty-nine of the 45 drug products were approved in the US before receiving approval in any other country. Sixteen of the novel drugs approved in 2015 were deemed “first in class”, often with a new mechanism of action, an indication of innovation in the US drug market. Twenty-one novel drugs approved in 2015 were approved to treat rare or “orphan” diseases that impact fewer than 200,000 patients in the US.

The FDA CDER report cited above also focuses on the high level of innovation in 2015 drug approvals. Twenty-seven of the 45 novel drugs approved in 2015 fell into one or more expedited categories, demonstrating that pharmaceutical manufacturers and the FDA are working to bring valuable life-saving medications to market.

This was demonstrated by the following approval categories:

• 24 Priority Reviews due to the potential for a significant advance in medical care. As a result, these drugs are targeted for a six-month review instead of the standard 10-month review goal.
• 14 Fast Track Approvals indicate drugs with the potential to address unmet medical needs.
• 10 Breakthrough Therapies indicate that the drugs’ preliminary clinical evidence demonstrated substantial improvement in at least one clinically-significant endpoint over other available therapies. Breakthrough status is designed to help shorten the development time of a potential new drug therapy.
• 6 Accelerated Approvals, which allow early approval of a drug for a serious or life-threatening illness and offer a benefit over current treatments. Once accelerated approval is granted, the drug undergoes additional testing to confirm that benefit. This process expedites availability of the drug to patients in need.

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. How do you keep up to date on new and novel drug approvals?

To view the FDA’s CDER Novel Drugs Summary report, visit https://public4.pagefreezer.com/browse/FDA/10-06-2024T13:24/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2015