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December 14, Boehringer Ingelheim
Ingelheim announced that its rare skin disease-targeted biologic, pesolimab (trade name: Spevigo), has been approved by the National Food and Drug Administration (NMPA) of China for the treatment of adult episodes of
generalized pustular psoriasis (GPP).
According to the Boehringer Ingelheim press release, the drug is a monoclonal antibody that blocks the activation of the interleukin-36 receptor (IL-36R), inhibits IL-36 signaling, and is also the first therapeutic drug
approved in China specifically for the treatment of adult GPP attacks.
Previously, the drug has been included in the breakthrough therapy variety and priority review
in China.
Generalized pustular psoriasis (GPP) is a rare, heterogeneous, life-threatening neutrophilic dermatosis
.
Patients have a varied clinical course, with some patients having recurrent disease with recurrent exacerbations and others with persistent and intermittent flare-ups
.
Although acute episodes of GPP vary in severity, complications such as sepsis and multisystem organ failure can be life-threatening
if left untreated.
Pesolimab (formerly known as spersolimab, spesolimab) is a humanized antagonistic monoclonal IgG1 antibody that binds to IL-36R and blocks IL-36R-36R-induced IL-36R activation in human IL-36α, IL-36β, and IL-36γ, thereby inhibiting pro-inflammatory and profibrotic pathways
in inflammatory skin diseases.
According to an earlier press release issued by Boehringer Ingelheim, pesolimab is an investigational therapy
specifically targeting the IL-36 pathway for the treatment of acute exacerbations of GPP.
In addition, the drug is being developed for the prevention of acute attacks of GPP and the treatment of other neutrophilic skin diseases such as palmoplantar impetigo and hidradenitis
suppurativasa.
in inflammatory skin diseases.
Pesolimab approval is based on its global pivotal EffisayilTM
1 Study Phase 2 clinical results
.
The study showed that 54.
3% of patients achieved no visible pustules on the skin after 1 week of pesolimab treatment; In 42.
9% of patients, clearance or near-clearance of skin symptoms was achieved with pesolimab for 1 week
.
At the same time, the safety data of pesolimab were acceptable throughout the study, and common adverse events in patients included fever and mild to moderate infection
.
3% of patients achieved no visible pustules on the skin after 1 week of pesolimab treatment; In 42.
9% of patients, clearance or near-clearance of skin symptoms was achieved with pesolimab for 1 week
EffisayilTM, Director of the Department of Dermatology, Huashan Hospital Affiliated to Fudan University
Professor Xu Jinhua, China Chief Investigator of Phase 2 Clinical Trial 1, said: "As the first monoclonal antibody of its kind to block the IL-36 receptor, the approval of San Lizo is of
breakthrough significance in the development of GPP diagnosis and treatment in China and even the world.
For patients with GPP attacks, the main demand is to control severe skin pustules and systemic symptoms, and San Lizo can help GPP patients quickly control skin pustules to help patients get rid of unbearable skin lesions and itching as soon as possible, greatly improving the quality of life of patients with such rare skin diseases, and bringing innovative 'sharp tools'
to doctors and patients to fight diseases.
”
Dr.
Bowen Dong, Head of Boehringer Ingelheim's Human Medicines Business in Greater China, said: "San Lizo, an innovative drug for rare skin diseases, is an innovative product developed and registered simultaneously by Boehringer Ingelheim worldwide, and we are very proud to bring this innovative drug 'zero day' to China
, thanks to the Chinese government's policy of encouraging innovation and accelerated review and approval of new drugs.
We would like to thank the Chinese researchers and patients who actively participated in the international clinical research of San Richland for contributing 'Chinese power'
to global research.
" In the future, we will actively work with all parties in the industry to provide more patient services in addition to innovative products, jointly promote the construction of GPP patient diagnosis and treatment ecosystem, and help patients return to health and high quality of life
.
" ”
Resources:
Resources:
[1] Heavy! Boehringer Ingelheim Rare Skin Disease Targeted Biologics San Lizo ® Approved in China .
Retrieved Dec 14，2022, from
https://mp.
weixin.
qq.
com/s/-KB0RxmkON_bOOWLZm8w9g
Retrieved Dec 14，2022, from https://mp.
weixin.
qq.
com/s/-KB0RxmkON_bOOWLZm8w9g
[2] Boehringer Ingelheim's first-of-its-kind immunological new drug Spesolimab submitted a marketing application in China for the treatment of the onset of generalized pustular psoriasis.
Retrieved Oct 26，2021,
from
Retrieved Oct 26，2021, from [3] Phase II clinical trial results of spesolimab spesolimab, the first drug in its kind for rare skin diseases.
Retrieved Dec 23，2021, from https://mp.
weixin.
qq.
com/s/euMld8UujNtl9FCNpArllg [3] Phase II clinical trial results of spesolimab spesolimab, the first drug in its kind for rare skin diseases.
Retrieved Dec 23，2021, from https://mp.
weixin.
qq.
com/s/euMld8UujNtl9FCNpArllg
