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FDA Approves BOTOX (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

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FDA Approves BOTOX (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

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FDA Approves BOTOX (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

Press Release
--BOTOX? is the First Neurotoxin Treatment Approved to Treat Pediatric Patients, 2 to 17 Years of Age, with Upper Limb Spasticity----Approval Marks 10th BOTOX? Therapeutic Indication in its 30th Anniversary Year--
DUBLIN,?June 21, 2019?/PRNewswire/ --?Allergan plc?(NYSE: AGN) today announced that the?U.S. Food and Drug Administration?(FDA) approved the company's supplemental biologics application (sBLA) for BOTOX??for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX??was granted a six-month Priority Review by the?FDA, which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care. The?FDA?is also reviewing an additional sBLA for the use of BOTOX? to treat pediatric patients with lower limb spasticity, with a decision expected in the fourth quarter of this year. Damage to the brain and spine can result in spasticity, which is often observed as muscle tightness and stiffness in the upper and lower limbs. Upper limb spasticity can interfere with movement at the joints of the upper limb?and its severity can range from mild to severe muscle stiffness.?Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke, which is a group of disorders affecting one's ability to move and maintain balance and posture. "Watching a child suffering with any degree of upper limb spasticity is very difficult," said?David Nicholson,?Chief Research?and Development Officer,?Allergan. "This FDA approval is special to all of us at?Allergan?because we can now provide children and their caregivers an advancement in pediatric care with BOTOX?. This milestone underscores our constant focus on innovation and builds on our 30-years of research and development efforts with BOTOX??since?FDA?approval of blepharospasm and strabismus in 1989. We also look forward to the?FDA's?decision on pediatric lower limb spasticity and continuing to serve our patients globally." The?FDA?approval is based on data from two Phase 3 studies evaluating the safety and efficacy of BOTOX??in over 200 pediatric patients with upper limb spasticity. These trials included a?12-week, double-blind study and a one-year open-label extension study. The approved recommended dose per treatment session is 3 Units per kilogram to 6 Units per kilogram divided among affected muscles of the upper limb. The total dose in pediatric patients should not exceed 8 Units per kilogram body weight or 300 Units, whichever is lower, in a 3-month interval. Treatment with BOTOX??is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed. "Pediatric upper limb spasticity is a significant concern and can negatively impact a child's development and quality of life," said?Mark Gormley, Jr.?M.D., Pediatric Rehabilitation Medicine Specialist, Gillette Children's Specialty Healthcare-St. Paul. "Because spasticity is particularly debilitating to growing children, it requires ongoing care. BOTOX??has a well-established safety and efficacy profile and I believe it will be an important treatment option in helping successfully manage upper limb spasticity in children and adolescents." Allergan?is committed to providing resources and services, such as the BOTOX??Savings Program, to help ensure BOTOX??is accessible and affordable to patients. Over the past 30 years, more than 100 million vials of BOTOX??and BOTOX??Cosmetic (onabotulinumtoxinA) have been distributed worldwide. With more than 3,700 articles on BOTOX??and BOTOX??Cosmetic published in scientific and medical journals, BOTOX??neurotoxin is one of the most widely researched medicines in the world. BOTOX??(onabotulinumtoxinA) Important?Information Indications BOTOX??is a?prescription?medicine?that?is?injected?into?muscles and?used:
  • to treat increased muscle stiffness in children 2 to 17 years of age with upper limb spasticity
  • to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
Treatment?with?BOTOX??in children 2 to 17 years of age with upper limb spasticity is not meant?to?replace?existing?physical therapy?or other rehabilitation?that?may?have been?prescribed. It?is not?known?whether BOTOX??is safe?or effective?for other types of muscle spasms. IMPORTANT SAFETY INFORMATION BOTOX??may?cause serious?side?effects that can be?life?threatening.?Get medical?help right away?if?you have?any?of?these?problems?any?time?(hours to?weeks) after?injection of?BOTOX?:
  • Problems swallowing, speaking, or breathing,?due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects.?The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
There has not?been?a?confirmed?serious case?of?spread?of?toxin?effect?away?from the?injection?site?when?BOTOX??has been?used?at?the?recommended?dose?to treat?blepharospasm or strabismus. BOTOX??may?cause?loss of?strength?or general muscle?weakness,?vision problems,?or?dizziness within?hours to?weeks?of?taking?BOTOX?.?If this happens,?do not?drive?a?car,?operate machinery,?or do other?dangerous activities. Do not receive?BOTOX??if?you:?are allergic to?any?of?the?ingredients in?BOTOX??(see?Medication?Guide?for ingredients);?had?an?allergic reaction?to?any?other botulinum?toxin?product?such?as?Myobloc??(rimabotulinumtoxinB),?Dysport??(abobotulinumtoxinA), or?Xeomin??(incobotulinumtoxinA); have?a?skin?infection?at the?planned?injection?site. The?dose?of?BOTOX??is?not the?same?as,?or?comparable?to, another botulinum?toxin product. Serious?and/or immediate allergic?reactions?have?been reported?including?itching,?rash,?red?itchy?welts,?wheezing,?asthma?symptoms,?or dizziness or?feeling?faint.?Get?medical help?right?away?if?you?experience?symptoms;?further injection?of?BOTOX??should?be?discontinued. Tell?your doctor about?all?your muscle?or?nerve?conditions?such?as ALS or Lou?Gehrig's disease,?myasthenia?gravis, or Lambert-Eaton syndrome,?as you may?be?at?increased?risk of?serious side?effects?including?difficulty?swallowing?and difficulty?breathing?from?typical doses of?BOTOX?. Cornea?problems?have?been reported.?Cornea?(surface?of?the?eye) problems have?been?reported?in?some?people?receiving?BOTOX??for their?blepharospasm, especially?in?people?with?certain?nerve?disorders. BOTOX??may?cause?the?eyelids to?blink less,?which?could?lead?to?the?surface?of?the?eye?being?exposed?to?air more?than?is usual.?Tell your doctor if?you?experience?any?problems?with?your eyes while?receiving?BOTOX?.?Your doctor?may?treat?your eyes with?drops, ointments,?contact?lenses,?or with?an?eye?patch. Bleeding behind the?eye?has?been reported.?Bleeding?behind?the?eyeball?has been?reported?in?some?people?receiving?BOTOX??for their?strabismus.?Tell your doctor if?you?notice?any?new visual problems?while?receiving?BOTOX?. Bronchitis?and upper?respiratory?tract infections (common colds) have been reported.?In pediatric patients treated with BOTOX??for upper limb spasticity, upper respiratory tract infections were reported more frequently. Tell?your doctor about?all?your medical?conditions,?including?if?you:?have?or have?had?bleeding?problems;?have?plans to?have?surgery;?had?surgery?on?your face;?weakness of?forehead?muscles;?trouble?raising?your eyebrows;?drooping eyelids;?any?other?abnormal?facial change;?are?pregnant?or?plan?to?become?pregnant (it?is not?known?if?BOTOX??can?harm?your unborn baby); are breastfeeding?or plan?to?(it?is not?known?if?BOTOX??passes?into?breast?milk). Tell?your doctor about?all?the?medicines?you take,?including?prescription?and over-the-counter medicines,?vitamins,?and?herbal supplements.?Using?BOTOX??with certain?other medicines may?cause?serious?side?effects.?Do not start any?new medicines?until you have?told?your doctor that?you?have?received BOTOX??in the past. Tell?your doctor if?you?received?any?other botulinum?toxin?product?in?the?last?4 months;?have?received?injections?of?botulinum?toxin?such?as?Myobloc?,?Dysport?, or?Xeomin??in?the?past (tell?your doctor exactly which?product?you?received);?have recently?received?an?antibiotic by?injection;?take?muscle?relaxants;?take?an?allergy or cold?medicine;?take a?sleep?medicine;?take?aspirin-like?products?or?blood thinners. Other side?effects of?BOTOX??include:?dry?mouth,?discomfort?or pain?at?the injection?site,?tiredness,?headache,?neck?pain,?eye?problems:?double?vision, blurred?vision,?decreased?eyesight,?drooping?eyelids,?swelling?of?your eyelids, dry?eyes, drooping eyebrows; and upper respiratory tract infection. For more?information?refer to?the?Medication?Guide?or talk with?your doctor. You?are encouraged?to?report?negative?side?effects?of?prescription?drugs to?the FDA.?Visit?www.fda.gov/medwatch?or call 1-800-FDA-1088. Please see BOTOX??full?Product Information?including Boxed Warning and?Medication Guide. Please see BOTOX??Cosmetic full?Product Information?including Boxed Warning and?Medication Guide. About?Allergan plc Allergan plc?(NYSE: AGN), headquartered in?Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.?Allergan?markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care,?Allergan?has built one of the broadest pharmaceutical and device research and development pipelines in the industry. With colleagues and commercial operations located in approximately 100 countries,?Allergan?is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit?Allergan's?website at?www.Allergan.com. Forward-Looking Statement Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect?Allergan's?current perspective on existing trends and information as of the date of this release. Actual results may differ materially from?Allergan's?current expectations depending upon a number of factors affecting?Allergan's?business. These factors include, among others, the difficulty of predicting the timing or outcome of?FDA?approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for?Allergan'sproducts; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS?, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences;?difficulties or delays in manufacturing; and other risks and uncertainties detailed in?Allergan's?periodic public filings with the?Securities and Exchange Commission, including but not limited to?Allergan's?Annual Report on Form 10-K for the year ended?December 31, 2018?and?Allergan'sQuarterly Report on Form 10-Q for the period ended?March 31, 2019. Except as expressly required by law,?Allergan?disclaims any intent or obligation to update these forward-looking statements. CONTACTS:?? Allergan: Investors: Manisha Narasimhan, PhD (862) 261-7162 Christine Chiou (862) 261-7396 Media: Amy Rose (862) 289-3072 Lisa Kim (714) 246-3843

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