A closer look at CDER’s novel drug approvals in 2022

Regulatory NewsRegulatory News | 11 January 2023 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a report on the 37 new drug therapies the Center approved in 2022, highlighting which had received expedited development and review status, first cycle approval, and met Prescription Drug User Fee Program Act (PDUFA) VII goal dates for acting on applications.
“We approved many drugs in 2022 for patients with few or no treatment options,” CDER Director Patrizia Cavazzoni, said in a message summarizing the scope of the center’s drug reviews for the year. “Other approvals offered improvements in efficacy, safety, or ease of use.”
For the third year in a row, the COVID-19 pandemic was acknowledged as an obstacle to reviewing drug applications at CDER. “It’s important to recognize that our staff—as well as our outside experts—continue to contend with the COVID-19 pandemic,” CDER wrote in the report. “We have all had to deal with health issues and other pandemic-related disruptions as we perform our critical work of reviewing drug applications and deciding to approve therapies. Yet, despite these ongoing disturbances, our staff remains committed to the task at hand: ensuring new safe and effective drugs are approved for patients and consumers in a timely manner.”
CDER noted in their report that 25 of 37 drugs (68%) were approved in the US before other countries. The Center also approved 36 of 37 drugs (97%) prior to the PDUFA goal date. Of the 37 novel drug approvals in 2022, 28 drugs (76%) were approved on the first cycle without CDER having to ask a sponsor for more information.
“This high percentage partly reflects the extent to which CDER staff provide clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive drug assessment,” the report stated.
Concerning novel drug approvals with expedited development and review status, 24 of 37 approvals (65%) in 2022 belonged to one or more of FDA’s Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs in their application process, CDER said. Specifically, 12 of 37 novel drugs (32%) were granted Fast Track status, 13 of 37 novel drugs (35%) were designated as Breakthrough Therapies, 21 of 37 drugs (57%) were designated Priority Review, and 6 of 37 drugs (16%) were approved under the Accelerated Approval pathway.
CDER also approved 20 of 37 novel drugs (54%) in 2022 as first-in-class drugs with different mechanisms of action than currently available therapies, and 20 of 37 novel drugs (54%) given orphan drug designation for rare or “orphan” diseases. Additionally, CDER highlighted two novel drugs—Cibinqo for untreatable moderate-to-severe atopic dermatitis, and Vtama as a topical medication for plaque psoriasis—as being notable approvals in 2022 (RELATED: CDER approved 37 novel drugs in 2022, its lowest number since 2016, Regulatory Focus 05 January 2023).
Many novel drugs belonged to one or more pathways or designations in 2022. Overall, 4 novel drugs (Amvuttra, Cibinqo, Relyvrio, and Vivjoa) received two designations, 5 drugs (Camzyos, Pluvicto, Tzield, Voquezna Triple Pak, and Ztalmy) had three designations, 8 drugs (Enjaymo, Kimmtrak, Krazati, Opdualag, Pyrukynd, Spevigo, Sunlenca, and Vonjo) had four designations, and 6 drugs (Elahere, Lunsumio, Lytgobi, Tecvayli, Terlivaz, and Xenpozyme) had five designations.
In their report, CDER also noted that it approved 25 drugs in 2022 that had been approved for new indications, and expanded indications for 12 drugs to pediatric populations.
CDER recognized the contributions of many different stakeholders in the process of reviewing drugs at FDA, both within the agency and outside it. “We consult outside scientific experts, patients and patient advocates, industry representatives, academics, and other community members in the drug development and review process. We consider their expertise and opinions very carefully. We want to ensure we have the perspectives of many different stakeholders before making regulatory decisions that may affect the health and well-being of Americans,” the report concluded.
New Drug Therapy Approvals 2022


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