It’s been a banner year in the new drug approval business, and now FDA has made it official: The Center for Drug Evaluation and Research (CDER) approved 59 novel drugs and biologics in 2018, surpassing previous high marks and improving on recent gains. Additional new products approved by the Center for Biologics Evaluation and Research (CBER) further boost the total.
While there’s some variation in the final numbers because analysts define innovative new products differently, it’s clear that industry investment and regulatory support combined to move many important new medicines to market efficiently to provide more treatments for a range of critical conditions. The “class of 2018” has 16 new cancer drugs, including several indicated for genetically defined conditions. There also was a number of new treatments for rare diseases, along with the first cannabidiol-based medicine and the first drug to treat smallpox. Nearly all the new drugs were approved in one review cycle, and three-fourths were approved first in the U.S.
To continue the emphasis on advancing innovation in drug development, FDA commissioner Scott Gottlieb recently announced plans to establish a new office of drug development science at the agency. The aim is to develop and authorize new tools and methods able to reduce the cost and uncertainty in testing and reviewing new medicines. This Office of Drug Evaluation Science will be part of CDER’s Office of New Drugs (OND) and will work to implement new methods for clinical outcome assessments, biomedical informatics and biomarker development. Additional efforts will aim to devise more standardized tools for capturing and formatting safety data to achieve more consistent review of this information.
Jan 11, 2019