In 2023, the US FDA approved 55 new drugs, making the second most in history, and there have been breakthroughs in gene therapy, respiratory fusion virus, Alzheimer’s disease and other fields, among which Pfizer has become the big winner with seven approvals, and the most promising new drug in the future is Leqembi, an Alzheimer’s disease drug cooperated by Biogen and Eisai.
The number of new drug approvals has grown significantly, and gene therapy has come to the fore
The U.S. FDA approved 55 new drugs (small molecules and biologics) in 2023, an increase of 50% from 37 in 2022, the second highest total number in history, second only to 59 in 2018, and the gap between the number of approvals in 2023 and 2022 may be due to the impact of the epidemic, which led to delays in the approval schedule.
In terms of therapeutic areas, cancer oncology continues to be the leader with the most approved new drugs (13 types, accounting for 24% of the total), neurological diseases such as Alzheimer’s and migraine are second (9 drugs, accounting for 16%), infectious infectious diseases and blood-related diseases are tied for third place (5 each, accounting for 9%), and it is worth noting that 28 (51%) of the 55 new drugs approved this year are orphan drugs for rare diseases, providing new options for patients who urgently need new treatments.
The FDA approved a number of different gene therapies, vaccines, and blood preparations this year, most notably expensively priced gene therapies, including Casgevy, the first CRISPR–Cas9-based gene-editing drug, priced at $2.2 million, and Lyfgenia (priced at $3.1 million) for the same indication (sickle anemia), and Roctavian (priced at $2.9 million) for the treatment of severe hemophilia A in adults, and Elevidys ($3.2 million) for the treatment of Josin muscular dystrophy, a rare disease caused by an abnormality in the body’s X chromosome, which causes weakness, weakness and muscle atrophy of the myofibrous membranes.
The RSV vaccine is available for the first time, and Alzheimer’s disease is a new breakthrough
Another big news for 2023 is the approval of the respiratory fusion virus (RSV) vaccine, with GSK spearheading Arexty for seniors over 60 in May, followed by Pfizer’s Abrysvor for pregnant women and seniors over 60, and the approval of Beyfortus, an antibody drug from Sanofi and AZ, for the prevention of RSV infection in infants, with sales expected to reach $1.3 – $1.7 billion by 2028.
As for the high-profile Alzheimer’s disease, Leqembi, a collaboration between Biogen and Eisai, is the first clinical trial to support a drug that can effectively clear amyloid plaques in the brain, and the first β amyloid antibody drug to be fully approved through tradition in recent years, bringing new hope to Alzheimer’s disease patients, while Leqembi’s rival, Eli Lilly’s antibody drug donanemab, also showed positive data in the phase 3 trial, the FDA It expects to respond to its fully approved applications in early 2024.
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In 2023, Pfizer took the lead with the most approvals (seven), more than double the number of approvals of any other company, and the last time a single company received so many approvals was back in 2019, when Novartis received six approvals.
Pfizer’s new drug approvals include multiple myeloma drug Elrexfio, growth hormone Ngenla in collaboration with OPKO, Litfulo, a first-in-class treatment for severe alopecia areata, Abryvso, an RSV vaccine, and Paxlovid, a fully approved COVID-19 antiviral drug, while the remaining two approved drugs were acquired by Pfizer in 2022 through acquisitions of other companies, namely the ulcerative colitis drug Velsipity (acquired for $6.7 billion). Arena) and Zavzpret, a nasal spray-type migraine drug (from the $11.6 billion acquisition of Biohaven).
Other competitors such as GSK, Biogen, Chiesi and UCB received three approvals each. GSK’s Myelofibrosis drug Ojjaara, kidney disease drug Jesduvroq and RSV vaccine Arexvy, Biogen’s ALS drug Qalsody, Alzheimer’s drug Leqembi co-developed with Eisai and Zurzuvae postpartum depression drug co-developed with Sage, Chiesi is Fulsuvez for rare skin diseases, and two enzyme replacement therapies Lamzede and Elfabrio, UCB is approved for Bimzelx for the treatment of plaque psoriasis and the myasthenia gravis drugs Zilbrysq and Rystiggo.
AZ’s RSV antibody drug Beyfortus and Alzheimer’s disease Leqembi may be the most commercially promising of these drugs approved in 2023, with Beyfortus expected to reach a maximum sales of $1.9 billion, and Leqembi benefiting from a large Alzheimer’s disease patient population, with a maximum sales of $4.8 billion.
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