Btobioinnovation.com
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation jcm9144@gmail.com
SPECIAL REPORT
US FDA/CDER Novel Drug Approvals for 2023
According to the latest report from the US FDA’s Center for Drug Evaluation and Research (CDER), the health agency has approved 55 novel drugs in 2023.
The comprehensive list of active ingredient and indication can be found in the following document.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023
2023 Major outcomes.
New CDER approvals were significantly higher than last year when the US agency granted only 37 new entities.
The main therapeutic areas covered were: 17 in oncology, 6 in neurology, 6 in immune disorders, 5 in infectious diseases, 5 in metabolic diseases and 3 in ophthalmology.
Small molecules represented 55% of all the approvals, monoclonal antibodies 22%, peptides and proteins 14%.
Regulatory pathways (not mutually exclusive) were: Priority review: 24 Orphan drug designation: 18 Fast track designation: 16 Accelerated approval: 9 Breakthrough therapy: 9
In 2023, the US FDA Center for Biologics Evaluation and Research (CBER) has also approved 17 new Biologics Licence Applications (BLAs).
On December 8, the US FDA approved Casgevy and Lyfgenia, representing the first cell-based gene therapy for the treatment of sickle cell disease (SDC). Casgevy, is the first FDA approved therapy utilising CRISPR/Cas9, a genome editing technology.
Paris, January 2, 2024
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