Neurogenic forced urinary muscle overactivity of new drugs! AbbVie Botox Botox (Paso) US Entry Review: Treatment of Children 5-17 Years!

, June 24, 2020 /PRNewswire
/ -- AbbVie has announced that the U.SFood and Drug Administration (
FDA) has accepted a request for a supplemental biologics license (sBLA) to seek to expand Botox.-- A, Botox A) prescription information, used to combat choline drug inshorted, intolerable or for any reason unwilling to continue anti-choline drugs in pediatric patients (5-17 years), to treat an internal nervous system disease (e.gspinal weakness, spinal cord injury) associated with the symptoms and signs of hyperactivity of the muscles (bladder muscle)BOTOX ® is the first and only neurotoxin approved for use in adult patients to treat urine leakage (incontinence) caused by bladder hyperactivity due to neurological disorders, and the drug is specifically used in adult patients who still have urine leakage or are unable to tolerate side effects after testing an anticholinergic drugBOTOX ® temporarily reduce muscle contraction by blocking the transmission of nerve impulses to the muscles (in this indications is the bladder muscle) and selectively preventing the release of the neurotransmitter acetylcholine at the nerve muscle jointsthe sBLA aims to expand the boTOX ® for children aged 5-17The sBLA was based on data from a random, double-blind Phase III study and a long-term extended study in children who evaluated the safety and efficacy of Botox in more than 100 cases of neurogenic aggressiveurisieThe sBLA will be reviewed through a standard 10-month review cycle, with the Prescription Drug User Charges (PDUFA) target date for the first quarter of 2021"
FDAaccepting this application, underscores our continued commitment to pursuing the full potential of BOTOX ® to serve patients with a variety of diseases and clinical needs," said Mitchell FBrin, Chief Scientific Officer and Senior Vice President of theNeurogenic Stressed Urthuria (Photo: epainassist.com) Currently, children with neurogenic urinary hyperactivity have very limited options for treatment after the failure of anticholinergic drug therapy and before surgeryIf approved, BOTOX ® would be the first neurotoxin therapy approved for the treatment of neurotoxin therapy in children with insufficient response to the anticholinergic drug "Over time, many children with internal neurological disorders develop bladder and kidney damage, and treatment is critical," said Paul F Austin, director of pediatric urology at Texas Children's Hospital and M.D., at Baylor College of Medicine, Current treatment options usually include anticholinergic drugs, and long-term use needs to be carefully considered in addition to surgery BOTOX ® treating children with neurogenic urinary hyperactivity show promising clinical outcomes that will meet unmet and ongoing medical needs in children and adolescents "
neurogenic urinary hyperactivity stems from the inability of the spinal cord and bladder to communicate effectively As a result, the bladder muscles (forced urination muscles) contract involuntarily, increasing pressure in the bladder and reducing bladder capacity, leading to frequent and accidental urination Without adequate treatment with clean intermittent catheterization and anticholinergic drugs, this condition may require extensive bladder forming (a widerange surgical procedure to expand the bladder by using a part of the patient's intestines) to prevent kidney damage there are many reasons the excessive activity of the neurogenic urinary muscle in children, such as transverse myelitis, spinal cord injury, and spina bifida Of these, spina bifida is the most common cause, affecting 15-2,000 of the more than 4 million babies in the United States each year More than 90% of people with spina bifida have urinary system symptoms Botox, developed by ElJian (acquired by AbbVie), is a highly purified type Botox, a neuroconductive blocker used to treat overactive muscles Botox was first approved in 1989 for the treatment of face spasms and squinting, and was approved in 2000 for neck dystonia, which has since expanded into the beauty field, including wrinkle removal, thin face, removal of eyebrow lines and fishtail patterns In recent years, Botox has also been approved for treatment of upper limb spasms, chronic migraines, neuroincontinence, bladder hyperactivity, cramps, and severe underarm sweating (hyperperchon) in the U.S., Botox has been so far The FDA approved for 11 therapeutic indications Over the past 30 years, more than 100 million bottles of Botox ® and Botox ® Cosmetic (Botox A) have been sold worldwide, and more than 3,700 articles have been published in scientific and medical journals Botox ® neurotoxins are one of the most widely studied drugs in the world (BioValleyBioon.com) original source: FDA
Accepts Supplemental Biologics License application (sBLA) for BOTOX ® (onabotulintoxinA) for the treatment of the patient of the Patients with The S Detrus Overactivity .