2018: A Record Year for New Drug Approvals

​We thought there would be no better way to kick-off our PharmaBeat blog series for the year than to recap the drug approval landscape from 2018. Of greatest interest are the novel drug approvals which contain new molecular entities that have not been previously approved. These drugs often help address unmet needs and advance patient care, and can provide insights into the innovation of the pharmaceutical industry.

Drug approvals in the US are of interest to Canadians, as we often see drugs coming to Canada about a year after approval by the FDA. Last year saw a record number of 59 new drug approvals by the FDA’s Center for Drug Evaluation and Research, and two recombinant therapies by their Center for Biologics Evaluation and Research – bringing the total to 61 new molecular entities. Interestingly, 19 of the new drug approvals were for first in class medications emphasizing the innovation we are seeing in the pharmaceutical industry over the last few years, and 43 were given priority review status for their potential to provide a significant advance in medical care. Of note, the majority of the drug approvals in the US were for rare diseases (affecting less than 200 000 patients) which are often conditions with limited or no treatment options, and an area of unmet need.

In Canada, we saw 27 new active substances approved by Health Canada in 2018. Although fewer than South of the border, we look forward to keeping our eye on some of these recent FDA approvals that may be in the pipeline for Canada.