New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.
The FDA’s two main drug review centers — the Center for Drug Evaluation (CDER) and Research and the Center for Biologics Evaluation and Research (CBER) — in 2022 approved a total of 49 new therapies. Of these, 37 had been approved by CDER and the remaining, including several gene therapies, were approved through CBER.
The 2022 approvals through Center for Drug Evaluation target many different disease areas, including COVID-19, HIV, smallpox, influenza, and H. pylori infection. Also approved were therapies for two severe and progressive neurological conditions, amyotrophic lateral sclerosis and spinal muscular atrophy.
“2022 marked the third consecutive year that COVID-19 has taken its toll on the global community,” Patrizia Cavazzoni, M.D., director, Center for Drug Evaluation and Research at the FDA, said in the report. “Mpox also emerged as a public health concern. Despite these hardships, we approved many therapies to prevent, diagnose, and treat a wide range of diseases and conditions.”
More than half of these new approvals (20) were for drugs to treat patients with rare diseases. In oncology, approvals included treatments for lung cancer, prostate cancer, uveal melanoma and types of breast cancer, among other kinds of cancers.
In 2022, CDER approved the 40th biosimilar, as well as two interchangeable biosimilars. There are now four approved interchangeable biosimilars. Additionally, 20 drugs were first in class, including:
Of the drugs that were approved last year, 12 had been granted fast track designation, 13 had received breakthrough designation, and 21 had received priority review. Six of the approvals were accelerated approvals, which is a pathway that allows therapies for serious conditions to be approved based on a surrogate endpoint. These approvals include:
The FDA’s Center for Biologics Evaluation and Research approvals in 2022, include vaccines for COVID-19 and a measles, mumps, and rubella, as well as several gene and other novel therapies. These products, however, have some of the highest list prices on new drug approvals. Some of these approvals include: