ICYMI: 3 charts that show why 2014 was a milestone year for US novel drug approvals
On Thursday, FDA Commissioner Margaret Hamburg published a blog post in which she hailed 2014 as "another strong year for novel drug approvals" in the United States.
2014 was an impressive year for novel drugs by several metrics. As Hamburg notes, there were a record 15 approvals for drugs to treat rare diseases (the previous high being 13 approvals 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," she wrote. "And here’s another point of interest—to date, 15 of the approvals have been first in their class drugs, another indicator of their potentially strong clinical impact."
And as the following charts from the FDA demonstrate, the U.S. had a stellar year when it came to getting new molecular entities and biologics applications approved. In fact, all 35 of the new molecular entity (NME) NDAs and Biologics License Applications (BLAs) submitted to the Center for Drug Evaluation and Research (CDER) were approved (note: the following charts have been slightly modified in order to better accommodate mobile devices):
Furthermore, the U.S. had one of its best years in terms of the percentage of new active substances that it launched on the world market. The following graph shows the share of new active substances launched since 2000 in the U.S. versus other countries:
And finally, the U.S. enjoyed a near-record approval action rate for NMEs, with more than 80% of NME actions to date leading to approvals:
As Hamburg states, 34 out of the 35 drugs approved so far in 2014 were approved before their PDUFA date and "23 of the 35 drugs were available to patients in the United States before they were available to patients in Europe."
From novel (but expensive) options for hep C patients such as Gilead's Sovaldi and Harvoni, to even more recently-approved drugs such as Blincyto for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, 2014 was a stellar year indeed for American pharma and patients.