Abstract
During 2019, the US Food and Drug Administration (FDA) approved 48 new drugs (38 New Chemical Entities and 10 Biologics). Although this figure is slightly lower than that registered in 2018 (59 divided between 42 New Chemical Entities and 17 Biologics), a year that broke a record with respect to new drugs approved by this agency, it builds on the trend initiated in 2017, when 46 drugs were approved. Of note, three antibody drug conjugates, three peptides, and two oligonucleotides were approved in 2019. This report analyzes the 48 new drugs of the class of 2019 from a strictly chemical perspective. The classification, which was carried out on the basis of chemical structure, includes the following: Biologics (antibody drug conjugates, antibodies, and proteins); TIDES (peptide and oligonucleotides); drug combinations; natural products; and small molecules.
Highlights
CIBER-BBN, Networking Centre on Bioengineering, Biomaterials and Nanomedicine, Department of Organic Chemistry, University of Barcelona, 08028 Barcelona, Spain
2018, we asked the following question: will this increasing trend of both kinds of drug continue in the coming years? We and other analysts were cautious in this regard [2,3,4], since the approval of a new drug by the corresponding agencies involves many variables that are difficult to predict
In addition to the two ADCs based on MMAE, a peptide of marine origin, three more peptides and two oligonucleotides were received the green light from the Food and Drug Administration (FDA)
Summary
In terms of the number of drugs approved by the Food and Drug Administration (FDA), 2019. Biologics are clearly consolidated in the drug arena, accounting for more than 25% (58 out of 220) of all drugs approved in the last five years (2015–2019). In 2019, the Center for Biologics Evaluation and Research (CBER) has added 10 new approvals, including three vaccines and one gene therapy [10]. This number clearly exceeds those of the previous years
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
