CDER Approves 27 Novel Drugs in First Half of 2021

July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER approving 27 NMEs during the first six months of the year.

The novel drugs approved this year by CDER are treatments for a wide range of health conditions and diseases, including, among others:

  • Lymphoma;
  • Alzheimer’s disease;
  • Schizophrenia/bipolar I disorder;
  • Non-small cell lung cancer;
  • Endometrial cancer;
  • Bile duct cancer;
  • Attention-deficit/hyperactivity disorder;
  • Multiple sclerosis;
  • Duchenne muscular dystrophy;
  • Multiple myeloma;
  • Paroxysmal hemoglobinuria;
  • Yeast infections;
  • HIV; and
  • Chronic heart failure.

“Although there have been concerns about potential delays in drug approvals due to the backlog of manufacturing inspections, we haven’t seen that impact in the numbers,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “This list of newly approved drugs touches patients across the spectrum of care and demonstrates how important new drug development is in making a difference in those patients’ lives,” he said.

CDER Director Dr. Patrizia Cavazzoni, who was promoted to this position earlier this year, announced last week that her former role as principal deputy director will be filled by Jacqueline Corrigan-Curay, J.D., M.D. Corrigan-Curay, who most recently served as acting director of FDA’s Office of Medical Policy, will be succeeded in that role by M. Khair ElZarrad, Ph.D., M.P.H.

“Jacqueline brings to the position a unique legal, scientific, policy, and clinical background,” Cavazzoni wrote in a July 6 email to CDER staff, citing Corrigan-Curay’s work on “implementing medical policy programs and strategic initiatives for real-world evidence, drug labeling, prescription drug promotion, clinical trial oversight, and innovative trial design.”

CDER states on its webpage covering novel drug approvals that this listing “does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved this year by the Center for Biologics Evaluation and Research” (CBER). CBER has approved three biological license applications (BLAs) through June of 2021; those products are designed to treat multiple myeloma, B-cell lymphoma and thermal burns. CBER approved seven BLAs during the same period in 2020.