NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
No Result
View All Result
Home ALL Healthcare

FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity

by Ed Johnson
July 30, 2021
A A

— 6.7 million adults in the U.S. are living with spasticity across a variety of neurologic conditions
— BOTOX® has demonstrated efficacy and has an established safety profile with over 10 years of clinical use in adult upper limb spasticity

NORTH CHICAGO, Ill., July 29, 2021 /PRNewswire/ — Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of BOTOX® to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment include additional muscles of the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus), as well as intrinsic hand muscles (lumbricals and interossei) and thumb muscles (flexor pollicis brevis and opponens pollicis). The label now includes the use of ultrasound as a muscle localization technique in adult spasticity.

“Today’s announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient’s quality of life,” said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, BOTOX® & Neurotoxins, AbbVie. “This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX® in upper limb spasticity treatment. BOTOX® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients.”

Spasticity in adults is commonly caused by stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Individuals with spasticity experience stiffness in the muscles of their upper and/or lower limbs, and may have difficulty with voluntary control. Upper limb spasticity can manifest as a bent elbow, an arm pressed against the chest, or a curled-in hand with a clenched fist, significantly hindering the patient’s ability to perform everyday activities. This can result in difficulty with posture and positioning, and severely interfere with normal muscular movement and function.

BOTOX® has been proven to significantly reduce muscle stiffness and is indicated for the treatment of spasticity in patients 2 years of age and older. This expanded BOTOX® dosing guidance provides physicians the ability to treat based on clinical assessment of a patient’s spasticity and anatomy while staying within the BOTOX® maximum cumulative dose of 400 Units in a 3-month period in adults. BOTOX® has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture. The safety profile of BOTOX® in adult upper limb spasticity remains the same, with the most common adverse reactions including nausea, fatigue, bronchitis, pain in extremity and muscular weakness.

“BOTOX® has demonstrated efficacy and safety for spasticity management at clinically proven doses,” said Kimberly Heckert, M.D., Director, Spasticity Management Fellowship, Thomas Jefferson University of Philadelphia. “This label expansion offers physicians and their patients living with spasticity another important tool as part of a comprehensive treatment plan for spasticity management.”

BOTOX® Training and Support Programs

Allergan offers a variety of expert-based BOTOX® education and technical training programs to help physicians enhance their clinical skills and injection practices. These training programs focus on using guidance techniques, such as EMG, nerve stimulation, and now ultrasound, to help localize muscles for BOTOX® injection in adults with spasticity. In addition, the company is committed to providing resources and services, such as the BOTOX® Savings Program, to help ensure BOTOX® is accessible and affordable to patients.

Tags: < Innovation
ShareTweetShareSend

Related Industries

Healthcare

Medtronic recommends rejection of below-market mini-tender offer by TRC Capital Investment Corporation

January 26, 2023
Healthcare

Johnson & Johnson Reports Q4 and Full-Year 2022 Results

January 25, 2023
Healthcare

Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries

January 18, 2023
Healthcare

AbbVie and Anima Biotech Announce Collaboration for the Discovery and Development of mRNA Biology Modulators against Oncology and Immunology Targets

January 11, 2023
Healthcare

Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders

January 7, 2023
Healthcare

Michelle Quinn Named Acting General Counsel for BD

January 7, 2023

Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders

January 7, 2023

...

Michelle Quinn Named Acting General Counsel for BD

January 7, 2023

...

Quadric and ams OSRAM collaborate to bring intelligent image sensors demonstration to CES

January 6, 2023

...

IHG Hotels & Resorts’ voco hotels Enters 2023 with Strong Growth Momentum

January 19, 2023

...

AbbVie and Anima Biotech Announce Collaboration for the Discovery and Development of mRNA Biology Modulators against Oncology and Immunology Targets

January 11, 2023

...

Medtronic recommends rejection of below-market mini-tender offer by TRC Capital Investment Corporation

January 26, 2023

...

ABB sells Power Conversion division to AcBel Polytech Inc. for $505 million

January 21, 2023

...

Randstad announces new leaders for Asia Pacific, North America and Technologies business.

January 6, 2023

...

chevron finalizes acquisition of beyond6 CNG fueling network

January 4, 2023

...

NORTH AMERICAN BUSINESS (www.na-biz.com) is a leading source of business and corporate news, information, industry trends, market updates and insights across a broad spectrum of industries in North America and worldwide.

INDUSTRIES

  • Aero
  • Agriculture
  • ALL
  • Automotive
  • Business Service
  • Chemical
  • Construction
  • Construction Materials
  • Consumer
  • Education
  • Energy
  • Entertainment
  • Environmental
  • F&B
  • Financial
  • Healthcare
  • Hospitality
  • Industrial
  • IT
  • IT Hardware
  • Logistic
  • Metal & Mining
  • Packaging & Paper
  • Rail
  • Real Estate
  • Telecom

CONTACT US

EDITORIAL:     editor#na-biz.com

PARTNERSHIP:     biz#na-biz.com

HUMAN RESOURCE:     hr#na-biz.com

* (replace # with @)

  • Official Site

Copyright © NA-BIZ.COM All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © NA-BIZ.COM All rights reserved.