– Dysport is now FDA-approved to treat both
upper and lower limb spasticity in pediatric patients two years of
age and older, including spasticity caused by cerebral palsy1 –
– Updated indication follows Ipsen and another
manufacturer's decision to selectively waive, with respect to each
other's toxin products only, their respective Orphan Drug
exclusivities in pediatric patients with cerebral palsy –
Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN;
ADR: IPSEY), announced today that the United States Food and Drug
Administration (FDA) has approved the expanded use of Dysport®
(abobotulinumtoxinA) in pediatric patients. When Dysport was first
FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was
granted Orphan Drug exclusivity for pediatric patients whose lower
limb spasticity was caused by cerebral palsy (CP).1 Similarly, in
2019, Dysport received FDA approval for the treatment of upper limb
spasticity in children two years of age and older, excluding upper
limb spasticity caused by CP, due to Orphan Drug exclusivity
granted to another manufacturer.1 Ipsen has worked with the FDA and
this manufacturer to selectively waive their respective
exclusivities to better support patient care. As a result, Dysport
is now FDA-approved to treat both upper and lower limb spasticity
in pediatric patients two years of age and older, including
spasticity caused by cerebral palsy.1
“The proactive step to resolve the uncertainty created by the
previous CP carveout enables us as physicians to prescribe
consistent therapy for pediatric patients experiencing both upper
and lower limb spasticity,” said Sarah Helen (Sally) Evans, MD,
Division Chief of Rehabilitation Medicine in the Department of
Pediatrics at the Children’s Hospital of Philadelphia. “This update
ensures patient care, and treating the child as a whole person, can
be the focus for physicians and their caregivers when making
treatment decisions for both upper and lower limb spasticity.”
“We’re proud to have proactively worked with the FDA and another
manufacturer to help physicians treat their patients in the manner
they deem best for their patients’ care,” said Kimberly Baldwin,
Vice President, Franchise Head, Neuroscience Business Unit, Ipsen.
“This effort illustrates our continued commitment to patients,
helping to ensure children living with cerebral palsy can access
the spasticity treatment that’s most appropriate for them.”
About Pediatric Spasticity
Spasticity is a condition in which there is an abnormal increase
in muscle tone or stiffness in one or more muscles, which might
interfere with movement.2
Spasticity affects the muscles and joints of the extremities,
and particularly impacts growing children.3 Spasticity is usually
caused by damage to nerve pathways in the brain or spinal cord that
control muscle movement, and may occur in association with CP,
spinal cord injury, multiple sclerosis, stroke, and brain or head
trauma.2,3
Symptoms of spasticity may include increased muscle tone, rapid
muscle contractions, exaggerated deep tendon reflexes, and/or
muscle spasms.2,3 The degree of spasticity can vary from mild
muscle stiffness to severe, painful, and uncontrollable muscle
spasms.2
Spasticity in children is a condition that causes muscle spasms
and increased muscle stiffness in either the upper and/or lower
limbs including the elbow, wrist, finger and calf muscles.1 When
muscle stiffness in the calf is intensified, it prohibits the ankle
from flexing as needed and causes the foot to be pointed down and
in.1,4
About Dysport® (abobotulinumtoxinA) for Injection
Dysport is an injectable form of botulinum toxin type A
(BoNT-A), which is isolated and purified from Clostridium bacteria
producing BoNT-A.1 It is supplied as a lyophilized powder.1 Dysport
has approved indications in the United States for the treatment of
adults with cervical dystonia (CD) and for the treatment of
spasticity in adult patients.1 Dysport is also the first
FDA-approved botulinum toxin for the treatment of both upper and
lower limb spasticity in children two years of age or older.1
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
Dysport® (abobotulinumtoxinA) for injection is indicated
for the treatment of:
- Spasticity in patients 2 years of age and older
- Cervical dystonia in adults
IMPORTANT SAFETY INFORMATION
Warning: Distant Spread of Toxin
Effect
Postmarketing reports indicate that the
effects of Dysport and all botulinum toxin products may spread from
the area of injection to produce symptoms consistent with botulinum
toxin effects. These may include asthenia, generalized muscle
weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia,
dysarthria, urinary incontinence, and breathing difficulties. These
symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and
there have been reports of death. The risk of symptoms is probably
greatest in children treated for spasticity, but symptoms can also
occur in adults treated for spasticity and other conditions,
particularly in those patients who have underlying conditions that
would predispose them to these symptoms. In unapproved uses and in
approved indications, cases of spread of effect have been reported
at doses comparable to or lower than the maximum recommended total
dose.
Contraindications
Dysport is contraindicated in patients with known
hypersensitivity to any botulinum toxin products, cow’s milk
protein, components in the formulation or infection at the
injection site(s). Serious hypersensitivity reactions including
anaphylaxis, serum sickness, urticaria, soft tissue edema, and
dyspnea have been reported. If such a reaction occurs, discontinue
Dysport and institute appropriate medical therapy immediately.
Warnings and Precautions
Lack of Interchangeability Between Botulinum Toxin
Products
The potency Units of Dysport are specific to the preparation and
assay method utilized. They are not interchangeable with other
preparations of botulinum toxin products, and, therefore, units of
biological activity of Dysport cannot be compared to or converted
into units of any other botulinum toxin products assessed with any
other specific assay method.
Dysphagia and Breathing Difficulties
Treatment with Dysport and other botulinum toxin products can
result in swallowing or breathing difficulties. Patients with
pre-existing swallowing or breathing difficulties may be more
susceptible to these complications. In most cases, this is a
consequence of weakening of muscles in the area of injection that
are involved in breathing or swallowing. When distant side effects
occur, additional respiratory muscles may be involved.
Deaths as a complication of severe dysphagia have been reported
after treatment with botulinum toxin. Dysphagia may persist for
several weeks, and require use of a feeding tube to maintain
adequate nutrition and hydration. Aspiration may result from severe
dysphagia and is a particular risk when treating patients in whom
swallowing or respiratory function is already compromised. Patients
treated with botulinum toxin may require immediate medical
attention should they develop problems with swallowing, speech, or
respiratory disorders. These reactions can occur within hours to
weeks after injection with botulinum toxin.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases,
amyotrophic lateral sclerosis, or neuromuscular junction disorders
(e.g., myasthenia gravis or Lambert-Eaton syndrome) should be
monitored particularly closely when given botulinum toxin. Patients
with neuromuscular disorders may be at increased risk of clinically
significant effects including severe dysphagia and respiratory
compromise from typical doses of Dysport.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood.
Based on effective donor screening and product manufacturing
processes, it carries an extremely remote risk for transmission of
viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There
is a theoretical risk for transmission of Creutzfeldt-Jakob disease
(CJD), but if that risk actually exists, the risk of transmission
would also be considered extremely remote. No cases of transmission
of viral diseases, CJD, or vCJD have ever been identified for
licensed albumin or albumin contained in other licensed
products.
Intradermal Immune Reaction
The possibility of an immune reaction when injected
intradermally is unknown. The safety of Dysport for the treatment
of hyperhidrosis has not been established. Dysport is approved only
for intramuscular injection.
Most Common Adverse Reactions
Adults with lower limb spasticity (≥5%): falls, muscular
weakness, and pain in extremity and with upper limb
spasticity (≥4%): muscular weakness.
Pediatric patients with lower limb spasticity (≥10%):
nasopharyngitis, cough and pyrexia and with upper limb
spasticity (≥10%): upper respiratory tract infection and
pharyngitis.
Adults with cervical dystonia (≥5%): muscular weakness,
dysphagia, dry mouth, injection site discomfort, fatigue, headache,
musculoskeletal pain, dysphonia, injection site pain, and eye
disorders.
Drug Interactions
Co-administration of Dysport and aminoglycosides or other agents
interfering with neuromuscular transmission (e.g., curare-like
agents), or muscle relaxants, should be observed closely because
the effect of botulinum toxin may be potentiated. Use of
anticholinergic drugs after administration of Dysport may
potentiate systemic anticholinergic effects, such as blurred
vision. The effect of administering different botulinum neurotoxins
at the same time or within several months of each other is unknown.
Excessive weakness may be exacerbated by another administration of
botulinum toxin prior to the resolution of the effects of a
previously administered botulinum toxin. Excessive weakness may
also be exaggerated by administration of a muscle relaxant before
or after administration of Dysport.
Special Populations
Use in Pregnancy
There are no adequate and well-controlled studies in pregnant
women. Dysport should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Based
on animal data, Dysport may cause fetal harm.
Pediatric Use
The safety and effectiveness of Dysport injected into proximal
muscles of the lower limb for the treatment of spasticity in
pediatric patients has not been established. Based on animal data
Dysport may cause atrophy of injected and adjacent muscles;
decreased bone growth, length, and mineral content; delayed sexual
maturation; and decreased fertility.
Geriatric Use
In general, elderly patients should be observed to evaluate
their tolerability of Dysport, due to the greater frequency of
concomitant disease and other drug therapy. Subjects aged 65 years
and over who were treated with Dysport for lower limb spasticity
reported a greater percentage of fall and asthenia as compared to
those younger (10% vs. 6% and 4% vs. 2%, respectively).
To report SUSPECTED ADVERSE REACTIONS or product complaints,
contact Ipsen at 1-855-463-5127. You may also report SUSPECTED
ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed
Warning and Medication Guide.
About Ipsen in North America Ipsen (Euronext: IPN; ADR:
IPSEY) is a global biopharmaceutical company focused on innovation
and specialty care. The company develops and commercializes
innovative medicines in three key therapeutic areas –Oncology,
Neuroscience and Rare Diseases. At Ipsen, we focus our resources,
investments and energy on discovering, developing and
commercializing new therapeutic options to provide hope for
patients whose lives are challenged by difficult-to-treat diseases.
Ipsen’s North American operations are located in Cambridge,
Massachusetts, one of the company’s three global hubs. Based in the
heart of Kendall Square, our fully integrated biopharmaceutical
business includes Commercial, Research & Development,
Manufacturing, and Global External Innovation and Partnering.
Combined with our Canadian headquarters in Mississauga, Ontario,
and other locations, Ipsen employs approximately 600 people in
North America. For more information please visit www.ipsenus.com or
www.ipsen.ca. Connect with us on Twitter and LinkedIn.
Forward-Looking Statement The forward-looking statements,
objectives and targets contained herein are based on the Group’s
management strategy, current views and assumptions. Such statements
involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from
those anticipated herein. All of the above risks could affect the
Group’s future ability to achieve its financial targets, which were
set assuming reasonable macroeconomic conditions based on the
information available today. Use of the words "believes",
"anticipates" and "expects" and similar expressions are intended to
identify forward-looking statements, including the Group’s
expectations regarding future events, including regulatory filings
and determinations, and the outcome of this study or other studies.
Moreover, the targets described in this document were prepared
without taking into account external growth assumptions and
potential future acquisitions, which may alter these parameters.
These objectives are based on data and assumptions regarded as
reasonable by the Group. These targets depend on conditions or
facts likely to happen in the future, and not exclusively on
historical data. Actual results may depart significantly from these
targets given the occurrence of certain risks and uncertainties,
notably the fact that a promising product in early development
phase or clinical trial may end up never being launched on the
market or reaching its commercial targets, notably for regulatory
or competition reasons. The Group must face or might face
competition from generic products that might translate into a loss
of market share. Furthermore, the Research and Development process
involves several stages each of which involves the substantial risk
that the Group may fail to achieve its objectives and be forced to
abandon its efforts with regards to a product in which it has
invested significant sums. Therefore, the Group cannot be certain
that favorable results obtained during preclinical trials will be
confirmed subsequently during clinical trials, or that the results
of clinical trials will be sufficient to demonstrate the safe and
effective nature of the product concerned. There can be no
guarantees a product will receive the necessary regulatory
approvals or that the product will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks
and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including
interest rate and currency exchange rate fluctuations; the impact
of 6 pharmaceutical industry regulation and health care
legislation; global trends toward health care cost containment;
technological advances, new products and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approval; the Group's ability to
accurately predict future market conditions; manufacturing
difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of
the Group’s patents and other protections for innovative products;
and the exposure to litigation, including patent litigation, and/or
regulatory actions. The Group also depends on third parties to
develop and market some of its products which could potentially
generate substantial royalties; these partners could behave in such
ways which could cause damage to the Group’s activities and
financial results. The Group cannot be certain that its partners
will fulfil their obligations. It might be unable to obtain any
benefit from those agreements. A default by any of the Group’s
partners could generate lower revenues than expected. Such
situations could have a negative impact on the Group’s business,
financial position or performance. The Group expressly disclaims
any obligation or undertaking to update or revise any
forward-looking statements, targets or estimates contained in this
press release to reflect any change in events, conditions,
assumptions or circumstances on which any such statements are
based, unless so required by applicable law. The Group’s business
is subject to the risk factors outlined in its registration
documents filed with the French Autorité des Marchés Financiers.
The risks and uncertainties set out are not exhaustive and the
reader is advised to refer to the Group’s 2019 Universal
Registration Document available on its website (www.ipsen.com).
DYSPORT is a registered trademark of Ipsen
Biopharm Limited ©2020 Ipsen Biopharmaceuticals, Inc. July 2020
NON-US-001645
1 Dysport (abobotulinumtoxinA) [Prescribing Information].
Cambridge, MA: Ipsen Biopharmaceuticals, Inc; July 2020. 2 National
Institute of Neurological Disorders and Stroke. Spasticity
Information Page.
https://www.ninds.nih.gov/Disorders/All-Disorders/Spasticity-Information-Page.
Accessed May 12, 2020. 3 American Association of Neurological
Surgeons. Spasticity page.
http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity.
Accessed May 12, 2020. 4 Delgado MR, Tilton A, Russman B, et al.
(2016). AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral
Palsy: A Randomized Controlled Trial. Pediatrics.
2016;137(2);1-9.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200709005981/en/
Maryann Quinn Director, Product Communications Tel:
+1-857-529-1151 E-mail: maryann.quinn@ipsen.com
Ipsen (EU:IPN)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Ipsen (EU:IPN)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024