2023-12-28 21:00:00
The U.S. FDA’s CDER (Center for Drug Evaluation and Research)has approved 56 new drugs so far this year.
The number of new drugs approved by CDER since 2016 is a 51% increase from 37 in 2022, the lowest number.
The 56 new drugs excluded biologic approvals.
Products such as vaccines, gene-edited drugs, and immunoglobulin products are subject to FDA’s CBER (CBER).Center for Biologics Evaluation and Research) is under the jurisdiction.
According to an analysis by consulting firm LEK Consulting, the most common treatment area receiving CDER approval this year is oncology, accounting for 31% of all green lights.
Notable cancer drugs that have received approval include Lilly’s Jaypirca, AbbVie/Genmab’s Epkinly, and multiple myeloma treatments J&J’s Elrexfio and Pfizer’s Talvey.
Drugs targeting neurological and autoimmune diseases each accounted for 11% of all approvals.
Biogen/Eisai received approval for the anti-amyloid antibody Leqembi for Alzheimer’s disease under the accelerated pathway in January.
Additionally, Arcadia Pharma’s Rett Syndrome treatment Daybue and Sage/Biogen’s depression treatment Zurzuvae also received a green light.
For autoimmune diseases, Pfizer and Lilly received approval for ulcerative colitis treatments Velsipity and Omvoh, respectively.
With six new drugs, Pfizer led the way in approving the most new drugs at CDER this year.
Notable new drugs include the full approval of Paxlovid, an oral COVID-19 treatment.
Biogen and AstraZeneca (AZ) ranked second and third with four and three approvals, respectively.
Other major pharmaceutical companies include GSK, BMS, Regeneron, Roche, Novo Nordisk, Sanofi, and Novartis.
Big Japanese pharma companies such as Astellas Pharma, Daiichi Sankyo, and Takeda are also noteworthy approved companies.
Additionally, successful drug approval companies include Travere Therapeutics, UCB, Incyte, Cidara Therapeutics, Pharming Group, and Protalix. BioTherapeutics), Bausch + Lomb, etc.
Additionally, Lexicon Pharma, OPKO Health, Amicus Therapeutics, Coherus BioSciences, SpringWorks Therapeutics, and CorMedix etc. were also on the list.
Meanwhile, the FDA’s CBER has approved 17 vaccines or Baologic to date.
Notable approvals include GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine, and Pfizer’s Abrydvo.
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