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▎The content team editor of WuXi AppTec recently, an oral antifungal drug, isaconazole sulfate capsules (English product name: CRESEMBA, Chinese product name: Kangxinbo), has been approved for marketing by the National Medical Products Administration (NMPA) of China , Used to treat invasive mucormycosis in adults
.
Public information shows that this is the first oral antifungal drug approved for the treatment of adult invasive mucormycosis in mainland China, bringing new treatment options to patients with such rare fungal infections with extremely high fatality rates
.
Screenshot source: NMPA official website, a fungal infectious disease with a high fatality rate.
Invasive mycosis (IFD) refers to fungi that invade the human body and grow and multiply in various tissues of the human body, including blood, leading to inflammation, tissue damage and Diseases characterized by pathophysiological changes such as organ dysfunction
.
Typical invasive fungal diseases mainly include invasive candidiasis, invasive aspergillosis and invasive mucormycosis
.
Among them, invasive mucormycosis is rarer than the previous two diseases, mainly caused by mucor infection, including Rhizopus and Rhizomucor
.
Invasive mucormycosis usually occurs in people with compromised immune systems, such as AIDS patients, diabetes patients, cancer patients, and people taking immunosuppressive agents
.
Many organs may be involved after illness, and the nose-orbital-brain, lung and other parts are common
.
Due to the difficult diagnosis of such diseases, the clinical symptoms of patients are very different, and the true incidence may be underestimated
.
What is more worrying is that for patients diagnosed with invasive mucormycosis, currently available treatment options are very limited, the prognosis of the patients is not optimistic, and the mortality rate is high
.
Epidemiology shows that the overall mortality rate of patients with invasive mucormycosis is close to 50%; the mortality rate of patients with hematological tumors, lung infections and central system involvement can reach 70%; and, if appropriate antifungal drugs are not provided in time, It will significantly increase the mortality of patients, and the mortality rate can reach 82.
9% after 12 weeks of delayed treatment
.
Therefore, for hematological malignancies, solid and hematopoietic stem cell transplantation, the use of glucocorticoids, diabetes and the use of antifungal drugs for prevention, patients with major trauma and other high-risk groups of invasive mucormycosis, the diagnosis and treatment should be carried out as soon as possible
.
Picture source: 123RF Oral Triazole Antifungal Drug Isaconazole Sulfate Capsule is an oral triazole antifungal drug
.
In 2015, Isaconazole Sulfate Capsules were approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of invasive aspergillosis and mucormycosis
.
In addition, in more than 60 countries and regions including the United Kingdom, France, and Switzerland, Isaconazole Sulfate Capsules have also been approved for marketing
.
Public information shows that isaconazole sulfate capsules can inhibit the cytochrome P450 (CYP)-mediated 14α-lanosterol demethylation, which inhibits the synthesis of ergosterol in the fungal cell membrane and the accumulation of the toxic intermediate product lanosterol.
In turn, the structure and function of fungal cell membranes are disturbed, permeability increases, and cell death
.
Compared with other azole drugs, the special molecular structure of isaconazole sulfate capsules allows the triazole ring to align with the binding pocket of the fungal CYP51 protein, thereby giving it a broader antifungal spectrum, including resistance to azoles.
Fungi etc.
all have good antibacterial activity
.
According to literature reports, isaconazole sulfate capsules have a broad antibacterial spectrum.
In vitro studies and clinical trials have shown that they have antibacterial activity against molds, yeasts, bidirectional fungi and some rare fungi; they are effective in treating special parts such as central nervous system infections.
; Its blood drug concentration is stable, safety and tolerability are good, and long-term use of drugs has few related adverse reactions
.
Image source: 123RF At present, several European guidelines have recommended isaconazole as the first-line treatment for invasive aspergillosis in patients with hematological diseases
.
We expect that with the approval of Isaconazole Sulfate Capsules on the market, it will bring new hope for the clinical treatment of invasive mucormycosis and help adults with invasive mucormycosis get timely treatment
.
Recommended reading Another new drug was approved in China, reducing the recurrence rate by more than 50% every year! You can get the first-line treatment of non-small cell lung cancer at home, and the new PD-L1 monoclonal antibody was approved for marketing.
Another new cancer drug was approved in China! This refractory tumor has a new choice for China to usher in the first new crown neutralizing antibody combination therapy! The risk of hospitalization and death of patients is significantly reduced in urgent clinical needs! To treat this disease, Stuximab was approved for marketing reference materials[1] Jiang Yingxuan, Zhu Liping.
Research progress of new antifungal drug Isaconazole[J].
Progress in Pharmacy,2021,45(06): 427-432.
[2] Information pending for receipt of drug approval documents from the China National Medical Products Administration on December 16.
Retrieved Dec 20, 2021, from https:// /20211216161759118.
html[3] Kangxinbo®, the first oral antifungal drug for invasive mucor in adults in China, was officially approved.
Retrieved Dec 20, 2021, from https://mp.
weixin.
qq.
com/s/ hGFFj_Nya1-FsfoDw2Gb5A[4] Pfizer signed an agreement to develop and sell CRESEMBA® (isaconazole) in China and the Asia-Pacific region.
Retrieved Dec 20, 2021, https://mp.
weixin.
qq.
com/s/JjsW-ENth9ky -hrVLBJWOw Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
Public information shows that this is the first oral antifungal drug approved for the treatment of adult invasive mucormycosis in mainland China, bringing new treatment options to patients with such rare fungal infections with extremely high fatality rates
.
Screenshot source: NMPA official website, a fungal infectious disease with a high fatality rate.
Invasive mycosis (IFD) refers to fungi that invade the human body and grow and multiply in various tissues of the human body, including blood, leading to inflammation, tissue damage and Diseases characterized by pathophysiological changes such as organ dysfunction
.
Typical invasive fungal diseases mainly include invasive candidiasis, invasive aspergillosis and invasive mucormycosis
.
Among them, invasive mucormycosis is rarer than the previous two diseases, mainly caused by mucor infection, including Rhizopus and Rhizomucor
.
Invasive mucormycosis usually occurs in people with compromised immune systems, such as AIDS patients, diabetes patients, cancer patients, and people taking immunosuppressive agents
.
Many organs may be involved after illness, and the nose-orbital-brain, lung and other parts are common
.
Due to the difficult diagnosis of such diseases, the clinical symptoms of patients are very different, and the true incidence may be underestimated
.
What is more worrying is that for patients diagnosed with invasive mucormycosis, currently available treatment options are very limited, the prognosis of the patients is not optimistic, and the mortality rate is high
.
Epidemiology shows that the overall mortality rate of patients with invasive mucormycosis is close to 50%; the mortality rate of patients with hematological tumors, lung infections and central system involvement can reach 70%; and, if appropriate antifungal drugs are not provided in time, It will significantly increase the mortality of patients, and the mortality rate can reach 82.
9% after 12 weeks of delayed treatment
.
Therefore, for hematological malignancies, solid and hematopoietic stem cell transplantation, the use of glucocorticoids, diabetes and the use of antifungal drugs for prevention, patients with major trauma and other high-risk groups of invasive mucormycosis, the diagnosis and treatment should be carried out as soon as possible
.
Picture source: 123RF Oral Triazole Antifungal Drug Isaconazole Sulfate Capsule is an oral triazole antifungal drug
.
In 2015, Isaconazole Sulfate Capsules were approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of invasive aspergillosis and mucormycosis
.
In addition, in more than 60 countries and regions including the United Kingdom, France, and Switzerland, Isaconazole Sulfate Capsules have also been approved for marketing
.
Public information shows that isaconazole sulfate capsules can inhibit the cytochrome P450 (CYP)-mediated 14α-lanosterol demethylation, which inhibits the synthesis of ergosterol in the fungal cell membrane and the accumulation of the toxic intermediate product lanosterol.
In turn, the structure and function of fungal cell membranes are disturbed, permeability increases, and cell death
.
Compared with other azole drugs, the special molecular structure of isaconazole sulfate capsules allows the triazole ring to align with the binding pocket of the fungal CYP51 protein, thereby giving it a broader antifungal spectrum, including resistance to azoles.
Fungi etc.
all have good antibacterial activity
.
According to literature reports, isaconazole sulfate capsules have a broad antibacterial spectrum.
In vitro studies and clinical trials have shown that they have antibacterial activity against molds, yeasts, bidirectional fungi and some rare fungi; they are effective in treating special parts such as central nervous system infections.
; Its blood drug concentration is stable, safety and tolerability are good, and long-term use of drugs has few related adverse reactions
.
Image source: 123RF At present, several European guidelines have recommended isaconazole as the first-line treatment for invasive aspergillosis in patients with hematological diseases
.
We expect that with the approval of Isaconazole Sulfate Capsules on the market, it will bring new hope for the clinical treatment of invasive mucormycosis and help adults with invasive mucormycosis get timely treatment
.
Recommended reading Another new drug was approved in China, reducing the recurrence rate by more than 50% every year! You can get the first-line treatment of non-small cell lung cancer at home, and the new PD-L1 monoclonal antibody was approved for marketing.
Another new cancer drug was approved in China! This refractory tumor has a new choice for China to usher in the first new crown neutralizing antibody combination therapy! The risk of hospitalization and death of patients is significantly reduced in urgent clinical needs! To treat this disease, Stuximab was approved for marketing reference materials[1] Jiang Yingxuan, Zhu Liping.
Research progress of new antifungal drug Isaconazole[J].
Progress in Pharmacy,2021,45(06): 427-432.
[2] Information pending for receipt of drug approval documents from the China National Medical Products Administration on December 16.
Retrieved Dec 20, 2021, from https:// /20211216161759118.
html[3] Kangxinbo®, the first oral antifungal drug for invasive mucor in adults in China, was officially approved.
Retrieved Dec 20, 2021, from https://mp.
weixin.
qq.
com/s/ hGFFj_Nya1-FsfoDw2Gb5A[4] Pfizer signed an agreement to develop and sell CRESEMBA® (isaconazole) in China and the Asia-Pacific region.
Retrieved Dec 20, 2021, https://mp.
weixin.
qq.
com/s/JjsW-ENth9ky -hrVLBJWOw Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
