FDA approves 35 novel drugs in 2014 boosted by breakthrough therapies

The US Food and Drug Administration has so far approved 35 novel drugs this year, compared to 27 last year, including new molecular entities (NMEs) submitted in New Drug Applications (NDAs) and new therapeutic biologics in Biologics License Applications (BLAs).

The stats have been reported by the Center for Drug Evaluation and Research (CDER)’s New Drug Review: 2014 Update. In the FDA Voice blog, FDA Commissioner Margaret Hamburg said: “The numbers don’t tell the full story. What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening diseases. That’s certainly the case for patients with rare diseases that affect 200,000 or fewer Americans. So far this year we’ve reached a milestone with a record 15 approvals for rare diseases. The previous high was 13 drugs in 2012. These results are all the more significant because patients with rare diseases often have few or no drugs available to treat their conditions.”