IRVINE, Calif.--(Business Wire)--
Allergan, Inc. (NYSE: AGN) today provided a further clarification on the U.S.
Food and Drug Administration`s (FDA) conclusion to its "Early Communication"
regarding a safety review of botulinum toxins in the United States.
On February 8, 2008, the FDA announced in an "Early Communication" that it was
reviewing certain serious adverse events following the use of botulinum toxins.
At the time, the FDA hosted a public teleconference, explaining that the review
involved only a "relative handful of serious adverse events" and that the
primary focus of the adverse events and the FDA`s review of them related to the
therapeutic use of BOTOX® to treat juvenile cerebral palsy and other large
muscle, lower limb spasticities, particularly at higher doses in neurologically
compromised patients.
Both before and after the Early Communication on February 8, 2008, Allergan
provided adverse event reporting information and analyses from its safety
database to the FDA. Yesterday and today, the FDA took three actions:
1. The FDA approved the application of Ipsen and Medicis to sell its botulinum
toxin in the United States for the treatment of cervical dystonia and glabellar
lines, and in connection therewith required, among other things, a boxed warning
regarding spread of toxin, safety language regarding the risks associated with the
non-interchangeability of botulinum toxins and a risk evaluation and mitigation
strategies (REMS) program to educate on spread and non-interchangeability;
2. The FDA informed Allergan that it believed Allergan should adopt the same
language on spread and non-interchangeability and a similar REMS to that
associated with DYSPORTTM;
3. The FDA announced the completion and results of its Early Communication and
hosted a press conference to provide context regarding its results and requests to
Allergan.
In its update to the early communication and press conference, the FDA explained
the results of its analysis and its conclusion that there have been infrequent
reports of serious adverse events associated with potential spread of product
from the site of injection and that the risk is greatest in children treated for
juvenile cerebral palsy but also in adults treated for spasticity or cervical
dystonia who have underlying conditions that would predispose them to these
symptoms. The proposed boxed warning provides similar context. Dr. Ellis Unger,
M.D., Deputy Director (Acting) of the FDA`s Office of Drug Evaluation, answered
questions and clarified the following in the press conference:
1. Dr. Unger explained that the reports of serious adverse events associated with
possible distant spread are infrequent, appear to be largely dose dependent and,
at labeled doses, BOTOX® and BOTOX® Cosmetic have a local effect;
2. Dr. Unger confirmed that there are no confirmed cases of serious adverse events
associated with possible distant spread with the use of BOTOX® Cosmetic at its
labeled dose;
3. After the completion of its analysis, the FDA evaluation continues to support
the recommendations made in February 2008;
4. Reports of serious adverse events, including hospitalization, have generally
related to high doses in compromised populations with co-morbidities.
Finally, to provide additional context, it is important to understand that while
bulk botulinum toxin is a potent biological agent, BOTOX® is not bulk botulinum
toxin. Instead, it is a finished medical product and a vial of BOTOX® contains
an extraordinarily minute amount (only four billionths of a gram) of botulinum
toxin. BOTOX® does not contain clostridium botulinum spores and does not cause
botulism at labeled doses.
Allergan will work with the FDA to appropriately update the label for BOTOX® and
BOTOX® Cosmetic in light of the FDA`s conclusions. In the interim, caution
should be exercised if treating neurologically vulnerable patients with high
doses of BOTOX®. Allergan would also like to emphasize the following
precautions:
* No other botulinum toxin is interchangeable with BOTOX® or BOTOX® Cosmetic and
caution should be exercised when substituting another botulinum toxin for BOTOX®
or BOTOX® Cosmetic.
* Patients should seek immediate medical attention if they develop the following
symptoms: unexpected loss of strength or muscle weakness, hoarseness or trouble
talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder
control, trouble breathing, trouble swallowing, double vision, blurred vision
and drooping eyelids.
Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Information
BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease
the severity of abnormal head position and neck pain associated with cervical
dystonia.
BOTOX® is also indicated for the treatment of strabismus and blepharospasm
associated with dystonia, including benign essential blepharospasm or VII nerve
disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in
restrictive strabismus, in Duane`s syndrome with lateral rectus weakness, and in
secondary strabismus caused by prior surgical over-recession of the antagonist
has not been established. BOTOX® is ineffective in chronic paralytic strabismus
except when used in conjunction with surgical repair to reduce antagonist
contracture.
And BOTOX® is indicated for the treatment of severe primary axillary
hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe
frown lines between the brows in people ages 18-65.
Important BOTOX® and BOTOX® Cosmetic (Botulinum Toxin Type A) Safety Information
BOTOX® and BOTOX® Cosmetic treatment should not be injected in the presence of
infection at the proposed injection site(s) and in individuals with known
hypersensitivity to any ingredient in the formulation.
Serious heart problems and serious allergic reactions have been reported rarely.
If you think you`re having an allergic reaction or other unusual symptoms, such
as difficulty swallowing, speaking or breathing, call your doctor immediately.
Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic
lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders
(e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX®
or BOTOX®
Cosmetic with caution. Patients with neuromuscular disorders may be at
increased risk of clinically significant systemic side effects with BOTOX® or
BOTOX® Cosmetic. For full prescribing information, please visit www.botox.com
and www.botoxcosmetic.com.
BOTOX® for Blepharospasm in Patients ≥ 12 Years of Age: Reduced blinking from
BOTOX® injection of the orbicularis muscle can lead to corneal exposure,
persistent epithelial defect and corneal perforation. The most frequently
reported treatment-related adverse reactions in these patients are ptosis
(20.8%), superficial punctate keratitis (6.3%) and eye dryness (6.3%).
BOTOX® for Strabismus in Patients ≥ 12 Years of Age: Inducing paralysis in one
or more extraocular muscles may produce spatial disorientation, double vision or
past pointing. The most commonly reported adverse effects are ptosis (16%) and
vertical deviation (17%).
BOTOX® for Cervical Dystonia in Adults: There have been rare cases of dysphagia
severe enough to warrant the insertion of a gastric feeding tube. The most
frequently reported adverse reactions in patients with cervical dystonia are
dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and
headache (11%).
BOTOX® for Severe Primary Axillary Hyperhidrosis Inadequately Managed with
Topical Agents: The most frequently reported adverse events (3 - 10%) are
injection site pain and hemorrhage, non-axillary sweating, infection,
pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and
anxiety.
BOTOX® Cosmetic for Temporary Improvement in the Appearance of Moderate to
Severe Frown Lines Between the Brows in Adults 18-65: The most common side
effects following injection include temporary eyelid droop and nausea. Localized
pain, infection, inflammation, tenderness, swelling, redness and/or
bleeding/bruising may be associated with the injection.
Forward-Looking Statements
This press release contains "forward-looking statements," including statements
regarding the safety, effectiveness and adverse events associated with BOTOX®.
These statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could vary materially from Allergan's expectations
and projections. Risks and uncertainties include, among other things, general
industry, biologic and pharmaceutical market conditions; technological advances
and patents attained by competitors; challenges inherent in the research and
development and regulatory processes; inconsistency of treatment results among
patients; potential difficulties in manufacturing; and governmental laws and
regulations affecting domestic and foreign operations. Additional information
concerning these and other risk factors can be found in press releases issued by
Allergan, as well as Allergan's public periodic filings with the Securities and
Exchange Commission, including the discussion under the heading "Risk Factors"
in Allergan's 2008 Form 10-K. Copies of Allergan's press releases and additional
information about Allergan is available on the World Wide Web at
www.allergan.com or you can contact the Allergan Investor Relations Department
by calling 1-714-246-4636.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a
multi-specialty health care company that discovers, develops and commercializes
innovative pharmaceuticals, biologics and medical devices that enable people to
live life to its greatest potential - to see more clearly, move more freely,
express themselves more fully. The Company employs approximately 8,000 people
worldwide and operates state-of-the-art R&D facilities and world-class
manufacturing plants. In addition to its discovery-to-development research
organization, Allergan has global marketing and sales capabilities with a
presence in more than 100 countries.
Allergan Contacts
Jim Hindman (714) 246-4636 (investors)
Joann Bradley (714) 246-4766 (investors)
Emil Schultz (714) 246-4474 (investors)
Caroline Van Hove (714) 246-5134 (media)
Kellie Reagan (714) 246-2278 (media)
Cathy Taylor (714) 246-5551 (media)
Copyright Business Wire 2009
