EUROPEAN COMMISSION APPROVES LABEL CHANGE FOR AERIUS®
(DESLORATADINE)
AERIUS® (desloratadine) now has one of the broadest antihistamine labels in the EU
and is indicated to treat all types of urticaria (hives)
KENILWORTH, N.J., April 9, 2008 – Schering-Plough Corporation
announced that the European Commission (EC) has adopted a Decision approving an
extension of one therapeutic indication of AERIUS® (desloratadine) for the current
European Union (EU) 27 member states as well as Iceland and Norway. The
Commission Decision broadened the indications for AERIUS to cover not only
“chronic idiopathic urticaria” but “urticaria”, a general term meaning hives. AERIUS
now has one of the broadest antihistamine labels in the EU. The new, broader
indication of “urticaria” encompasses urticarial diseases such as acute urticaria, coldinduced urticaria, demographic urticaria, solar-induced urticaria and histamine release
in urticaria, in addition to the prior indication of chronic idiopathic urticaria (CIU) or
hives of unknown origin. Appropriate revisions are now included in the Therapeutic
Indications section (4.1) and the Pharmacodynamic Properties section (5.1) of the
AERIUS Summary of Product Characteristics (SPC).
The updated AERIUS label is consistent with accepted guidelines from the
European Academy of Allergology and Clinical Immunology (EAACI) Dermatology
Section and the Global Allergy and Asthma European Network (GA2LEN), which
confirm “urticaria” as the accepted terminology for classification and recommend
nonsedating antihistamines as first line treatment for urticaria.1,2
“As a physician, it is very important to have a nonsedating antihistamine, like
AERIUS, indicated for the treatment of all types of urticaria according to our
guidelines,” said Torsten Zuberbier, M.D., Professor of Dermatology and Allergy,
University of Berlin.
In two placebo-controlled six week trials studying CIU – hives of unknown
cause – as a model for urticarial conditions, AERIUS was effective in relieving
pruritus and decreasing the size and number of hives by the end of the first
dosing interval. In each trial, the effects were sustained over the 24-hour dosing
interval. An improvement in pruritus of more than 50 percent was observed in
55 percent of patients treated with desloratadine compared with 19 percent of
patients treated with placebo. Treatment with AERIUS also significantly reduced
interference with sleep and daytime function, as measured by a four-point scale
used to assess these variables.
About Urticaria
Hives, or urticaria, are red, itchy, swollen areas of the skin (wheals) that can
vary in size from about 5 mm (0.2 inches) in diameter to 25 cm (10 inches) and
appear anywhere on the body. These wheals are caused by a chemical in the body
called histamine which is released from certain cells.3 An episode of hives can start as
itching, followed by swollen, red wheals. The itching may be mild or severe.
Scratching, alcohol beverages, exercise, and emotional stress may worsen the itching.4
In the EU, as many as 32 percent of allergy sufferers report urticaria among their most
prevalent allergy symptoms.5
About AERIUS
AERIUS (desloratadine) is a nonsedating antihistamine and is indicated in the
EU for the treatment of symptoms associated with allergic rhinitis (including
intermittent and persistent allergic rhinitis) and urticaria, or hives. AERIUS Tablets,
Orodispersible Tablets 5 mg and Oral Lyophilisate are approved to treat these
symptoms in patients 12 years of age and older. AERIUS Orodispersible Tablets 2.5
mg are approved to treat these symptoms in patients 6 years of age and older.6
AERIUS Syrup and AERIUS Oral Solution are both approved to treat these
symptoms in patients 1 year of age and older.6
The most common side effects in adults and adolescents with allergic rhinitis
and CIU were fatigue, dry mouth and headache.6 In clinical trials in a pediatric
population (children aged 6 months through 11 years), the overall incidence of
adverse events in children 2 through 11 years of age was similar for the AERIUS
syrup and placebo groups.6 In infants and toddlers aged 6 to 23 months, the most
frequent adverse events reported in excess of placebo were diarrhea, fever and
insomnia.6
Research shows AERIUS provides powerful morning symptom relief for
seasonal allergic rhinitis patients. In a study of 346 people with moderate-to-severe
seasonal allergic rhinitis, patients receiving AERIUS experienced significant
improvement in morning total symptom scores (which includes both nasal and non-
nasal symptoms) versus placebo.7 AERIUS offers demonstrated efficacy at the end of
the dosing interval.6
Schering-Plough markets desloratadine as prescription medicines under the
brand names AERIUS, AZOMYR and NEOCLARITYN in Europe and CLARINEX®
in the United States. AERIUS [AZOMYR] [NEOCLARITYN] [CLARINEX] builds
upon Schering-Plough’s heritage as a leader in discovery and development.
About Schering-Plough Corporation
Schering-Plough is an innovation-driven, science-centered global health care
company. Through its own biopharmaceutical research and collaborations with
partners, Schering-Plough creates therapies that help save and improve lives around
the world. The company applies its research-and-development platform to human
prescription and consumer products as well as to animal health products. In
November 2007, Schering-Plough acquired Organon BioSciences, with its Organon
human health and Intervet animal health businesses, marking a pivotal step in the
company's ongoing transformation. Schering-Plough’s vision is to “Earn Trust, Every
Day” with the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., and its Web
site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements relating to
AERIUS. Forward-looking statements relate to expectations or forecasts of future
events. Schering-Plough does not assume the obligation to update any forwardlooking statement. Many factors could cause actual results to differ materially from
Schering-Plough’s forward-looking statements, including market forces, economic
factors, product availability, patent and other intellectual property protection, current
and future branded, generic or over-the-counter competition, the regulatory process,
and any developments following regulatory approval, among other uncertainties. For
further details about these and other factors that may impact the forward-looking
statements, see Schering-Plough’s Securities and Exchange Commission filings,
including Part I, Item IA. “Risk Factors” in Schering-Plough’s 2007 10-K/A.
###
References:
1.
Zuberbier T, Bindslev-Jensen C, Canonica W, et al. Review article: EAACI/GA2LEN/EDF
guideline: definition, classification and diagnosis of urticaria. Allergy. 2006; 61: 316–320.
2.
Zuberbier T, Bindslev-Jensen C, Canonica W, et al. Review article: EAACI/GA2LEN/EDF
guideline: management of urticaria. Allergy. 2006; 61: 321–331.
3.
American Academy of Allergy, Asthma and Immunology. Allergic Conditions: Urticaria.
http://www.aaaai.org/patients/allergic_conditions/urticaria.stm. Accessed November 15, 2007.
4.
American College of Allergy, Asthma and Immunology. Urticaria.
http://www.acaai.org/public/advice/urtic.htm. Accessed November 15, 2007.
5.
“Understanding the Dynamics Surrounding Allergy Suffering and Treatment” Forbes Consulting
Group. 2005.
6.
7.
AERIUS [NEOCLARITYN] (summary of product characteristics). Schering Corporation.
Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group. Efficacy and tolerability
of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic
rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest. 2001; 21:25-32.