Recently, the US FDA Center for Drug Evaluation and Research (CDER) released the 2022 new drug approval report
.
According to the report, in 2022, a total of 37 new drugs were approved by the FDA, including 20 FIC therapies, such as Camzyos, the first myomyosin allosteric reversible inhibitor, Pluvicto, a treatment for advanced prostate cancer, Sunlenca, a new HIV drug, and Tzield
, a diabetes drug.
This time, we mainly sorted out some of the key products
.
Camzyos
BMS's Camzyos is the first allosteric reversible inhibitor
of myocardial myosin approved by the FDA at the end of April 2022.
It is used to improve cardiac function and relieve symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are rated 2 and 3 according to the New York Heart
Association's functional scale (NYHA).
oHCM is a chronic, progressive disease that thickens the heart wall, making it difficult for the heart to expand normally and fill with blood, leading to a variety of debilitating symptoms and cardiac dysfunction, which is also a common cause
of cardiac arrest in young people.
The launch of Camzyos will bring new treatment options
to oHCM patients.
Pluvicto
Novartis' Pluvicto was approved by the US FDA in March 2022 for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and androgen receptor signaling pathway inhibitors
.
Prostate cancer is a malignant tumor with a rapid increase in male incidence, and it often faces many problems
in clinical diagnosis and treatment, such as low early diagnosis rate, difficult surgical treatment, and advanced metastasis resistance.
Pluvicto is the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC, which combines a targeted compound (ligand) with a therapeutic radioisotope (radioactive particle
).
Sunlenca
Sunlenca is a long-acting HIV drug developed by Gilead, approved by the FDA at the end of December 2022, in combination with other antiretroviral (ARV) drugs for the treatment of HIV-1 infection in adults with multidrug-resistant (MDR) and multiple treatment experience (HTE), administered every six months, which is also the world's first approved HIV treatment drug to be administered twice a year
.
HIV, known as "acquired immunodeficiency syndrome", is a deficiency of low immune function caused by HIV infection
.
Sunlenca is a long-acting capsid inhibitor that inhibits HIV-1 replication primarily by interfering with multiple important steps of the viral life cycle, including capsid-mediated uptake of HIV-1 proviral DNA, viral assembly and release, and capsid core formation, and has no known cross-resistance to other existing drugs
.
Tzield
Provention Bio's Tzield is a monoclonal antibody that targets CD3 antigens on the surface of T cells, which binds to specific immune cells so that they no longer attack insulin-producing cells, and the drug can promote insulin secretion at the source, thereby achieving hypoglycemic effects
.
In November 2022, Tzield was approved by the FDA to delay or prevent type 1 diabetes in adults and people over 8 years old, and it is also the first drug
to delay the onset of type 1 diabetes.
Type 1 diabetes mellitus (T1D) is an autoimmune disease that often occurs
in childhood and adolescence because the pancreatic β cells are damaged, resulting in the inability to produce insulin normally.
In recent years, the incidence and prevalence of type 1 diabetes in children around the world have increased significantly, and before Tzield was launched, there was a huge unmet treatment need
for type 1 diabetes.
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