FDA approved 37 ‘novel’ drugs in 2022, says new analysis

Despite the fact the United States is still dealing with the COVID-19 pandemic, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) authorized a wide range of new, safe treatments in 2022.

According to the FDA’s yearly report on new drug therapy approvals, CDER authorized 37 “novel” drugs—drugs that had never before been approved or sold in the United States—in 2022, wrote CDER Director Patrizia Cavazzoni, M.D., in a blog post this week.

The FDA also authorized drugs for usage in fresh contexts, including new patient groups and purposes.

The 2022 approvals focus on a wide range of illness states. Medicines for COVID-19, HIV, smallpox, influenza, and Helicobacter pylori infection were all approved. Additionally, the FDA approved treatments for spinal muscular atrophy and amyotrophic lateral sclerosis, two serious and degenerative neurological diseases.

“Our commitment to the rare disease community continued in 2022 with more than half (20 of 37, or 54%) of our novel drug approvals for patients with rare diseases, who often have no or few treatment options,” says Dr. Cavazzoni.

CDER’s new drug approvals, year-by-year (Source: FDA)

About 32% of new treatments (or 12 out of 37) approved in 2022 by CDER were given Fast Track status. By improving the degree of contact between the FDA and drug developers and allowing CDER to examine elements of a drug application on a rolling basis, Fast Track facilitates the development and approval of novel drugs and biological products, the 2022 New Drug Therapy Approvals Report notes.

According to the report, some 13 of the 37 (or 35%) new medications CDER identified as “breakthrough” therapies in 2022. All of the Fast Track program’s elements are included in a designation as a “Breakthrough Therapy,” which also provides top managers’ engagement and intense FDA assistance during the medication development process.

The proportion of drug submissions CDER received in 2022 was comparable to that of the previous several years (and greater than average), indicating that the drug development industry continues to be characterized by innovation. CDER only approves applications for drugs and biologics if they satisfy the FDA’s stringent regulatory requirements.

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