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▎The content team editor of WuXi AppTec today, LEO Pharma announced that the U.
S.
FDA has approved the IL-13 inhibitor Adbry (tralokinumab) for the treatment of moderate to severe atopic patients who are 18 years of age or older and whose disease cannot be adequately controlled or treated by topical prescription therapies Adult patients with sexual dermatitis
.
Adbry can choose whether to combine with topical corticosteroids
.
The press release pointed out that Adbry is the first biological product approved by the US FDA to specifically bind to and inhibit IL-13 cytokines, which is a key driver of atopic dermatitis
.
This is also the 50th new drug approved by the US FDA in 2021
.
Atopic dermatitis is a chronic inflammatory skin disease, the main symptoms are severe itching and eczema lesions
.
More than 200 million patients worldwide are plagued by this disease
.
It can cause severe itching, insomnia and social pressure due to visible lesions, and have a serious negative impact on the quality of life of patients
.
The cause of atopic dermatitis is due to skin barrier dysfunction and immune disorders
.
Recent studies have found that a variety of cells in the skin tissues of patients with atopic dermatitis overexpress IL-13
.
Adbry is a fully humanized monoclonal antibody that binds to IL-13 with high affinity
.
It can not only block the binding of IL-13 and IL-13Rα1, but also block the binding of IL-13 and IL-13Rα2
.
It was originally developed by AstraZeneca.
LEO Pharma reached an agreement with AstraZeneca in 2016 to obtain Adbry's global development rights
.
▲Adbry (TRAL in the picture) binds to IL-13 to block its binding to IL-13Rα1 and IL-13Rα2 (picture source: reference [2]) Adbry's approval this time is based on 3 key points 3 According to the positive safety and efficacy results of the phase trial, a total of about 2,000 adult patients with moderate to severe atopic dermatitis were enrolled
.
The safety data evaluation comes from data obtained from 5 randomized double-blind, placebo-controlled trials.
In addition to the above 3 phase 3 clinical trials, it also includes a dose exploration trial and a vaccine response trial
.
All three key trials reached their primary endpoint at week 16, which was compared with placebo, Adbry (300 mg, once every 2 weeks as a monotherapy, or combined with topical corticosteroids as needed) reached EASI 75 (Eczema area and severity index improved by 75% or more from baseline), or IGA scores of 0 or 1 (representing complete or near complete skin symptoms), the proportion of patients was significantly higher
.
Moreover, the Adbry group was also significantly better than the placebo group on the key secondary endpoint of daily pruritus NRS response (≥4 points)
.
In terms of safety, Adtralza was well tolerated during treatment, and the overall frequency of adverse events was comparable to placebo
.
The most common adverse events were upper respiratory tract infections (mainly reported as the common cold), conjunctivitis, injection site reactions, and eosinophilia
.
"Today the FDA's approval of Adbry is a major milestone for LEO Pharma and the millions of patients with moderate to severe atopic dermatitis
.
"LEO Pharma's Chief Financial Officer and Acting CEO Mr.
Anders Kronborg said, "As our first biological product in the United States (approved), Adbry marks an important progress in our mission to advance medical dermatological care standards
.
"Reference: [1] LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis.
Retrieved December 28, 2021, from https :// Bieber (2020), Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis.
Allergy, DOI: 10.
1111/all.
13954 Disclaimer: WuXi The AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The opinions in the article do not represent WuXi AppTec's position, nor does it mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If needed For guidance on the treatment plan, please go to a regular hospital for treatment
.
S.
FDA has approved the IL-13 inhibitor Adbry (tralokinumab) for the treatment of moderate to severe atopic patients who are 18 years of age or older and whose disease cannot be adequately controlled or treated by topical prescription therapies Adult patients with sexual dermatitis
.
Adbry can choose whether to combine with topical corticosteroids
.
The press release pointed out that Adbry is the first biological product approved by the US FDA to specifically bind to and inhibit IL-13 cytokines, which is a key driver of atopic dermatitis
.
This is also the 50th new drug approved by the US FDA in 2021
.
Atopic dermatitis is a chronic inflammatory skin disease, the main symptoms are severe itching and eczema lesions
.
More than 200 million patients worldwide are plagued by this disease
.
It can cause severe itching, insomnia and social pressure due to visible lesions, and have a serious negative impact on the quality of life of patients
.
The cause of atopic dermatitis is due to skin barrier dysfunction and immune disorders
.
Recent studies have found that a variety of cells in the skin tissues of patients with atopic dermatitis overexpress IL-13
.
Adbry is a fully humanized monoclonal antibody that binds to IL-13 with high affinity
.
It can not only block the binding of IL-13 and IL-13Rα1, but also block the binding of IL-13 and IL-13Rα2
.
It was originally developed by AstraZeneca.
LEO Pharma reached an agreement with AstraZeneca in 2016 to obtain Adbry's global development rights
.
▲Adbry (TRAL in the picture) binds to IL-13 to block its binding to IL-13Rα1 and IL-13Rα2 (picture source: reference [2]) Adbry's approval this time is based on 3 key points 3 According to the positive safety and efficacy results of the phase trial, a total of about 2,000 adult patients with moderate to severe atopic dermatitis were enrolled
.
The safety data evaluation comes from data obtained from 5 randomized double-blind, placebo-controlled trials.
In addition to the above 3 phase 3 clinical trials, it also includes a dose exploration trial and a vaccine response trial
.
All three key trials reached their primary endpoint at week 16, which was compared with placebo, Adbry (300 mg, once every 2 weeks as a monotherapy, or combined with topical corticosteroids as needed) reached EASI 75 (Eczema area and severity index improved by 75% or more from baseline), or IGA scores of 0 or 1 (representing complete or near complete skin symptoms), the proportion of patients was significantly higher
.
Moreover, the Adbry group was also significantly better than the placebo group on the key secondary endpoint of daily pruritus NRS response (≥4 points)
.
In terms of safety, Adtralza was well tolerated during treatment, and the overall frequency of adverse events was comparable to placebo
.
The most common adverse events were upper respiratory tract infections (mainly reported as the common cold), conjunctivitis, injection site reactions, and eosinophilia
.
"Today the FDA's approval of Adbry is a major milestone for LEO Pharma and the millions of patients with moderate to severe atopic dermatitis
.
"LEO Pharma's Chief Financial Officer and Acting CEO Mr.
Anders Kronborg said, "As our first biological product in the United States (approved), Adbry marks an important progress in our mission to advance medical dermatological care standards
.
"Reference: [1] LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis.
Retrieved December 28, 2021, from https :// Bieber (2020), Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis.
Allergy, DOI: 10.
1111/all.
13954 Disclaimer: WuXi The AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The opinions in the article do not represent WuXi AppTec's position, nor does it mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If needed For guidance on the treatment plan, please go to a regular hospital for treatment
.
