2023 Saw Second-Highest Number of Drug Approvals in 30 Years
Cancer, neurology, infectious disease and hematology drugs gained the most new approvals.
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The US Food and Drug Administration (FDA) approved 55 novel drugs in 2023 – the second-highest figure in the last 30 years. This is almost a 50% increase compared to 2022, which saw 37 new approvals.
Small molecules and oncology take first place
All 55 drugs approved by the FDA’s Center for Drug Evaluation and Research (CDER) contain novel active ingredients not previously approved. The FDA also took steps such as expanding the conditions or patient populations for previously approved drugs, as well as making other drugs available over-the-counter, like the progestin-only contraceptive pill.
These novel drugs are separate from products such as vaccines and cell and gene therapies, which are approved by the FDA’s Center for Biologics Evaluation and Research (CBER).
In the CDER’s list, small molecules represented the largest drug modality with 34 approvals, followed by proteins (17 approvals) and oligonucleotides (4 approvals).
Cancer drugs gained the highest number of new approvals, with 13 novel therapies for oncology (24%). Second was neurology with a total of 9 approvals (16%) and both infectious disease and hematology were level with the third-highest number of approvals at 5 each (9%).
Selected novel drug approvals from 2023
For oncology, the blood cancer drug Elrexfio™ (elranatamab-bcmm) was granted accelerated approval in August. This is used to treat patients with multiple myeloma who have received at least four previous lines of therapy and have either relapsed or no longer respond to treatment.
A major breakthrough came from the approval of Alzheimer's drug Leqembi™ (lecanemab), which targets amyloid-beta plaques in the brain that are thought to be responsible for the disease. The approval came despite concerns over patient safety as well as its potential clinical benefits. A similar amyloid-targeting drug, donanemab, was denied approval as there was not enough trial data on patients who had been on the drug for at least 12 months. Further news on its fate is expected in 2024.
Weight loss drug Zepbound™ also earned approval amid surging interest in drugs to help facilitate weight loss. However, this is not classed as a “novel” approval, as it contains the active ingredient tirzepatide, previously approved in the type 2 diabetes drug MounjaroTM.
Antibody-based drug Beyfortus™ (nirsevimab-alip) earned approval to prevent serious respiratory disease in infants, caused by respiratory syncytial virus (RSV) infections. This is a leading cause of hospitalization for infants and can be fatal. Clinical trials showed the drug was highly effective at preventing lower respiratory tract disease over a five-month period, the duration of a typical winter RSV season.
Litfulo™ (ritlecitinib) was approved to treat alopecia areata, an autoimmune disorder that causes severe patchy hair loss across the scalp, face and body. It is also the first and only treatment approved by the FDA for adolescents over 12 years of age with the condition.
Finally, Zurzuvae™ (zuranolone) was approved to treat post-partum depression (PPD) – the first oral pill specific for the condition. Clinical trials demonstrated that a 2-week course of zuranolone rapidly improved PPD symptoms by day 15 of treatment, with some patients seeing improvements from as early as day 3.
New year, new drugs
With the dawn of the New Year, one novel drug has already been approved – Zelsuvmi™ (berdazimer) – for the treatment of molloscum contagioiusum, a common viral skin infection. With many new drugs expected to join this roster over the coming year, it is exciting to see what the future will bring.
