pLOG

2024-03-08

Summary of Key New Drug Launches in 2023: Who Will Be the Future Star with the Most Promising Prospects?

In 2023, the US FDA approved 55 new drugs, the second-highest number in history. Breakthroughs were made in areas such as gene therapy, respiratory syncytial virus, and Alzheimer's disease. Pfizer emerged as the big winner with seven approvals. The most promising new drug in the future is estimated to be Leqembi, a collaboration between Biogen and Eisai for Alzheimer's disease.

With a significant increase in the number of new drug approvals, gene therapy is gaining prominence.

The FDA approved 55 new drugs in 2023 (small molecules and biologics), a 50% increase compared to 37 in 2022, making it the second-highest in history, second only to 59 in 2018. The discrepancy in approvals between 2023 and 2022 may be due to delays caused by the pandemic.

In terms of therapeutic areas, oncology had the most approved new drugs (13, accounting for 24% of the total), followed by neurological diseases such as Alzheimer's and migraines (9, accounting for 16%), and infectious diseases and blood-related diseases tied for third place (each with 5, accounting for 9%). Of the 55 new drugs approved this year, 28 (51%) were orphan drugs targeting rare diseases, providing new options for patients in need of new treatments.

The FDA approved many different gene therapies, vaccines, and blood products in 2023, with the most notable being high-priced gene therapies. These include Casgevy, the first CRISPR–Cas9-based gene editing drug priced at $2.2 million, Lyfgenia for the same indication (beta-thalassemia) priced at $3.1 million, Roctavian for severe type A hemophilia in adults priced at $2.9 million, and Elevidys for Duchenne muscular dystrophy priced at $3.2 million. Duchenne muscular dystrophy is a rare disease caused by an abnormality in the X chromosome, resulting in the loss of a segment of the DMD gene, leading to muscle weakness, fragility, and atrophy.

The debut of the RSV vaccine and breakthroughs in Alzheimer's disease

Another major news in 2023 was the approval of respiratory syncytial virus (RSV) vaccines. GSK introduced Arexvy for adults aged 60 and older in May, followed by Pfizer's Abrysvor for pregnant women and adults aged 60 and older. In July, Sanofi and AZ's collaboration antibody drug Beyfortus was approved for preventing infant RSV infections. Sales of these products are expected to reach $1.3-1.7 billion by 2028.

As for the highly anticipated Alzheimer's disease, Leqembi, a collaboration between Biogen and Eisai, became the first drug clinically proven to effectively clear amyloid plaques from the brain. It is also the first beta-amyloid antibody drug to be fully approved through traditional means in recent years, bringing new hope to Alzheimer's patients. Donanemab, an antibody drug being developed by Eli Lilly, also showed positive data in Phase III trials, with FDA expected to respond to its full approval application in early 2024.

Which pharmaceutical company won the big prize of the year, and who will be the most promising star of tomorrow?

In 2023, Pfizer led the way with the most approvals (seven), more than double the quantity of any other company. The last time a single company received so many approvals was in 2019, when Novartis received six approvals.

Pfizer's newly approved drugs include Elrexfio for multiple myeloma, Ngenla, a growth hormone in collaboration with OPKO, Litfulo, a pioneering therapy for severe alopecia, Abryvso for RSV vaccination, and Paxlovid, a fully approved COVID-19 antiviral. The remaining two approved drugs were acquired by Pfizer in 2022 through acquisitions of other companies: Velsipity for ulcerative colitis (acquired from Arena for $6.7 billion) and Zavzpret for nasal spray migraine (acquired from Biohaven for $11.6 billion).

Other competing companies such as GSK, Biogen, Chiesi, and UCB each received three approvals. GSK's approvals include Ojjaara for myelofibrosis, Jesduvroq for kidney disease, and Arexvy for RSV vaccination. Biogen's approvals include Qalsody for amyotrophic lateral sclerosis, Leqembi for Alzheimer's disease in collaboration with Eisai, and Zurzuvae for postpartum depression in collaboration with Sage. Chiesi received approvals for Fulsuvez for treating rare skin diseases and enzyme replacement therapies Lamzede and Elfabrio. UCB received approvals for Bimzelx for plaque psoriasis and Zilbrysq and Rystiggo for myasthenia gravis.

AZ's RSV antibody drug Beyfortus and Leqembi for Alzheimer's disease developed in collaboration with Eisai may be the most commercially promising among the drugs approved in 2023. Beyfortus is expected to have peak sales of $1.9 billion, while Leqembi, benefiting from the large population of Alzheimer's patients, could have peak sales of up to $4.8 billion.

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