Allergan receives licence update for BOTOX® (botulinum toxin type A) increasing multidisciplinary team involvement in treatment of debilitating conditions
- Medicines and Healthcare Products Regulatory Agency (MHRA) grants licence update for BOTOX® permitting more healthcare practitioners to administer treatment for people with chronic migraine, post-stroke spasticity and bladder dysfunction –
- Licence change marks positive step forward for patients suffering with these debilitating conditions –
MARLOW, UNITED KINGDOM – 25 MARCH 2020 – Allergan today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for BOTOX® (botulinum toxin type A) across all of its approved indications in the UK. The product licence update makes clear that appropriately trained and qualified healthcare professionals, including specialist nurses and physiotherapists, are able to administer the product to patients. This update should help to remove any barriers in practice that may have been experienced by nurses and other therapists involved with the use of the product across neurology, rehabilitation and urology – ensuring easier access to treatment for these patients.
“The decision to increase the pool of healthcare professionals that can administer the product is positive, not only for the patient but also for us as healthcare practitioners,” said Susie Lagrata, Headache and Neuromodulation Lead Nurse, The National Hospital for Neurology and Neurosurgery. “This announcement acknowledges the significant role that nurses, as part of a multidisciplinary team, play in treating chronic migraine patients, while also making it easier for patients to receive this important therapy.”
“The management and care of patients with muscle spasticity after stroke is complex, with physiotherapists playing an integral role in rehabilitation,” said Dr. Rhoda Allison, Consultant Stroke Physiotherapist, Torbay and South Devon NHS Foundation Trust. “Ensuring that we are included as healthcare practitioners who can administer the product will allow us to more effectively treat patients who can benefit from treatment, and improve access to treatment.”
“This licence update reflects the work being undertaken by urology nurses – as recognised in the recently published supplement to the ‘Getting It Right First Time’ (GIRFT) Urology National Report, which showcases good practice case studies including establishing a nurse-led service. The GIRFT National report highlighted the need to reduce variations, improve productivity, quality and most importantly patient safety within the NHS,” said Julia Taylor, Past President of the British Association of Urological Nurses, Macmillan Consultant Nurse and Clinical Governance Lead, Urology, Salford Royal NHS Foundation Trust. “This is a significant step towards improvements and efficiencies within the NHS through innovations such as nurse-led clinics, which can ultimately lead to the delivery of high quality care whilst maintaining patient safety.”
Nancy Ghattas, UK & Ireland Associate Vice President and Country Manager, Allergan, said "This licence change reflects the important role that all members of a multidisciplinary team have in disease management, and ensures appropriate access to the product for patients who need it most in the UK."
Important Safety Information
BOTOX® is a prescription medicine that is injected into muscles and used in the treatment of: focal spasticity, including dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older; wrist and hand disability due to upper limb spasticity associated with stroke in adults; ankle and foot disability due to lower limb spasticity associated with stroke in adults; symptomatic relief of blepharospasm, hemifacial spasm and idiopathic cervical dystonia (spasmodic torticollis); prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine); management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics; overactive bladder with symptoms of urinary incontinence, urgency and frequency; neurogenic detrusor overactivity with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis.
Please see BOTOX® Summary of Product Characteristics for full product information.
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 https://www.allergan.co.uk/.
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’s products; 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, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Further information is available from: Allergan Limited, Marlow International, The Parkway, Marlow, Bucks SL7 1YL.