FDA approves Epson Bio to expand Dysport injection spree

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pharmaceutical(http://company(http://announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved the expansion of the scope of Dysport (Lischuto, abobotulinumAtoxin, A botulinum atoxin) injectionsThe scope of application is included in the treatment of upper limb spasms in children 2 years and older (excluding spasms caused by cerebral palsy (cerebral palsy, CP)This approval is based on data from a key Phase III clinical studyThe study was a randomized, double-blind, low-dose, multicenter study that enrolled 210 children aged 2-17 with upper limb spasms 　　The results showed that Dysport significantly improved spasm symptoms and reached the main therapeutic end: the use of an improved Ashworth scale (MAS) to measure elbow or wrist flexor muscles, and at week 6, the baseline of two Dysport high dose groups (8U/kg, 16U/kg) movement disorders achieved a statistically significant improvement compared to the Dysport low dose group (2U/kg) 　　For most children, Dysport treatment reduces spasms in both the upper and lower limbs for 12 weeks In the upper limb study, most patients were treated at 16-28 weeks, but some patients had longer remission durations 　　The most common adverse reactions are upper respiratory tract infections and pharyngitis 　　About Dysport
Dysport is an injectable Botulinum toxin type A, BoNT-A that is isolated and purified from the Clostridium difficile that produces BoNT-A, which is supplied as a freeze-dried powder In the United States, Dysport has been approved for the treatment of adult cervical vertebral tension disorder (CD) and the treatment of adult spasms 　　Dysport is the first and only FDA-approved Botox toxin for the treatment of upper limb and lower limb spasms in children two years of age or older 　　Dysport and all Botox products (http:// have a black-framed warning that the effects of Botox may spread from the injection site to other parts of the body, causing botulinum-like symptoms These symptoms include swallowing and breathing difficulties, which can be life-threatening 　　Dysport is prohibited for use in patients who are known to be allergic to any Botox toxin formulation or any ingredient, or to patients who are infected at the site of the proposed injection, or who are known to be allergic to bovine milk protein 　　Dysport's price unit is related to the preparation and analysis (http:// method used and is not interchangeable with other preparations for Botulinum toxin products