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Novel Drug Approvals for 2023

In 2023, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) hit a significant milestone, approving 55 new drugs, an increase of nearly 50% from last year and second only to the all-time high of 2018 . This number highlights the innovative trend in the pharmaceutical field and demonstrates the industry’s great success in different treatment areas. What is particularly eye-catching is that among the new drugs approved by the FDA in 2023, antibody drugs occupy a prominent position, including China’s domestic PD-1 monoclonal antibodies, which brings new hope to the medical community.

Among these 55 new drugs, oncology once again became the most approved treatment area, fully reflecting the medical community’s in-depth research on cancer treatment. At the same time, the fields of neurology and infectious diseases have also been recognized by the FDA, providing more treatment options for patients. The emergence of new drugs will promote the rapid development of medical technology and further promote progress in the health field.

It is worth mentioning that 2023 has also become a year of significant progress in the field of rare diseases, providing patients with new treatment options. Pfizer performed well this year. Not only did it become the company with the most approvals, it also launched a number of highly anticipated new products, covering multiple disease fields such as tumors, immunity, infection, and the nervous system.

In this dynamic year of medical innovation, it is worth noting that there are 6 new drugs that belong to the peptide drug category. They are:

1.Daybue (Trofinetide, Trofinetide)

Developer: Acadia Pharmaceuticals
Approval time: 2023-03-10
Indications: Rett syndrome
Delivery method: Oral solution (200 mg/ml), specific dosage is based on body weight
Introduction: It is used to treat Rett syndrome and is the first approved therapy for Rett syndrome. It exerts neuroprotective effects by enhancing synaptic activity and restoring synaptic structure.
2.Rezzayo (Rezafungin, Rezafungin)

Developer: Melinta Therapeutics/Cidara Therapeutics
Approval time: 2023-03-22
Indications: Candidemia and invasive candidiasis
Delivery method: Intravenous injection (200 mg once weekly)
Introduction: For the treatment of candidemia and invasive candidiasis, it is the first new treatment option approved for this indication in more than a decade.
3.Paxlovid (nirmatrelvir&ritonavir)

Developer: Pfizer
Approval time: 2023-05-25
Indications: Covid-19
Mode of delivery: Oral
Introduction: It is used to treat COVID-19 and reduce the severity of the disease by preventing the virus from multiplying. It contains two peptidomimetic molecules, nirmatrelvir and ritonavir.
4.Posluma (flotufolastat F 18)

Developer: Blue Earth Diagnostics
Approval time: 2023-05-25
Indications: Positron emission tomography imaging in patients with prostate cancer
Delivery method: Intravenous injection
Introduction: Positron emission tomography imaging for prostate cancer patients using PSMA targeting components for imaging.
5.Aphexda (Motixafortide, motixafortide)

Developer: BioLineRx
Approval time: 2023-09-08
Indications: Collection and subsequent autologous transplantation in patients with multiple myeloma
Delivery method: Subcutaneous injection
Introduction: For the collection and subsequent autologous transplantation of patients with multiple myeloma, stem cells are mobilized into the peripheral blood by CXCR4 antagonists.
6.Zilbrysq(Zilucoplan)

Developer: UCB
Approval time: 2023-10-17
Indications: Generalized myasthenia gravis in adults
Delivery method: Subcutaneous injection
Introduction: It is the first once-daily subcutaneous injection of gMG-targeted C5 complement inhibitor for the treatment of generalized myasthenia gravis in adults.
The approval of new drugs this year witnessed the joint efforts of medical research and industrial development, providing patients with more innovative treatments and writing a new chapter for building a healthier future.

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