The Center for Drug Evaluation and Research (CDER) approved 50 novel therapies in 2021 which are described in a recently released 26-page report (here) that discusses in some detail the 50 novel products and their bearing on treatment for patients. The report discusses the mechanistic pathway for approval and provides a list of all the novel products and their indications.
Some of the highlights of the report include:
- CDER identified 27 of the 50 (54%) novel drugs approved in 2021 as first-in-class.
- 26 (52%) of CDER’s 50 novel drug approvals were for rare or orphan diseases.
- 18 of the 50 novel drugs (36%) were designated by the Agency as Fast Track.
- 14 of the 50 (28%) novel drugs of 2021 were identified as Breakthrough Therapies.
- 34 of the 50 (68%) novel drugs approved in 2021 were granted priority review.
- CDER identified 14 of the 50 (28%) novel drugs as Accelerated Approvals.
- 49 of the 50 (98%) novel drugs approved in 2021 met their PDUFA goal date.
- 43 of the 50 (68%) of the novel drugs in 2021 were approved in the first review cycle.
- 38 of the 50 (76%) of the novel drugs were first approved in the United States.
This is quite a significant list of accomplishments for CDER and for the American public. Please read the report for additional details and congratulations to CDER for not only its outstanding response on the COVID pandemic but also on the approval accomplishments on bringing these 50 novel drug products to the most deserving stakeholders in the mix, the patients!