Galderma Announces Positive Outcome of European Decentralised Procedure for Approval of SOOLANTRA® (ivermectin) Cream 10mg/g...
March 27 2015 - 2:30AM
Business Wire
– Novel treatment option for rosacea
demonstrates efficacy in three Phase III studies –
Galderma, a global specialty pharmaceutical company focused on
dermatology, announced today a positive outcome of the European
Decentralised Procedure (DCP) for SOOLANTRA® (ivermectin) Cream
10mg/g for the once-daily topical treatment of inflammatory lesions
of papulopustular rosacea in adult patients. The Medical Products
Agency (MPA) in Sweden acted as Reference Member State (RMS) on
behalf of 28 EU Member States, which all agreed that SOOLANTRA
Cream can be approved.
“As a world leader in skin health, Galderma is committed to
providing innovative treatment options for clinicians and patients,
and the approval of SOOLANTRA Cream highlights our continuous
efforts,” said Stuart Raetzman, CEO of Galderma Pharma SA. “A clear
focus on skin health has helped us expand our rosacea franchise to
deliver more medicines that offer a novel approach, addressing
important patient needs.”
The Marketing Authorisation application of SOOLANTRA Cream was
based on three Phase III studies, which involved over 2,300
subjects. Two 12-week treatment vehicle-controlled studies
demonstrated superiority of SOOLANTRA Cream efficacy over vehicle
cream within 4 weeks. In a 16-week treatment active-controlled
study, SOOLANTRA Cream was shown to be superior to Metronidazole
7.5 mg/g cream twice-daily in reducing Inflammatory Lesion Counts
(ILC) as of Week 3 and until Week 16. After 16 weeks of treatment
with SOOLANTRA, the reduction in ILC reached 83.0% from baseline.
This is reflected in the European prescribing information.
While the SOOLANTRA Cream mechanism of action is not completely
understood, ivermectin – its active ingredient – has been reported
to have both anti-inflammatory and anti-parasitic properties.
“There are currently few effective treatments that reduce the
papules and pustules of rosacea, and these may take in excess of
four weeks to show results,” commented Jürgen Schauber, MD,
Ludwig-Maximilian University, Munich, Germany. “SOOLANTRA Cream has
demonstrated a quick onset and improved efficacy over an existing
reference treatment in clinical studies, making it a new
therapeutic option that meets the needs of rosacea patients.”
About Rosacea
Rosacea is a common inflammatory skin disease that presents
variable clinical characteristics, of which the most common are
flushing, permanent erythema, papules and pustules. It mainly
affects the central areas of the face, such as the cheeks and nose.
The disease affects both adult men and women, usually after the age
of 30. Additionally, symptoms such as stinging, burning and
increased sensitivity of the skin are common, and in some cases the
eyes can become red, dry and itchy.
Although the cause of the disease is still under debate, various
trigger factors are known, including spicy foods, alcohol,
emotional stress, sun/UV-exposure, hot baths and beverages.
Demodex, generally harmless mites, can also be found in the skin in
an elevated quantity in people with rosacea.
Rosacea may worsen over time if left untreated. People that
suspect they suffer from rosacea should visit their dermatologist
or healthcare provider for diagnosis, and discuss what treatment is
right for them. Because rosacea is a highly visible disease, it is
known to cause embarrassment and anxiety in some patients, which in
turn may cause frustration and have a negative impact on their
social life.
About Galderma
Galderma is a global company founded in 1981 committed to
delivering innovative medical solutions to meet the dermatological
needs of people throughout their lifetime, while serving healthcare
professionals around the world. The company has 34 wholly-owned
affiliates with a worldwide network of distributors and more than
5,500 employees. Galderma’s extensive product portfolio is
available in 80 countries and treats a range of dermatological
conditions including: acne, rosacea, onychomycosis, psoriasis and
steroid-responsive dermatoses, pigmentary disorders, skin cancer
and medical solutions for skin senescence.
Galderma is the operating company of Nestlé Skin Health, a
global leader focused on enhancing the quality of life by
delivering science-based solutions for the health of skin, hair and
nails. Five state-of-the-art R&D centers and six manufacturing
sites are dedicated to providing a wide range of innovative medical
solutions which meet the highest standards of safety and
efficacy.
Strategic Galderma brands include Epiduo®, Oracea®, Differin®,
Mirvaso®, Soolantra®, Tri-Luma®, Loceryl®, Cetaphil®, Metvix®,
Azzalure®/ Dysport®, Restylane® and Emervel®.
For more information, please visit Galderma’s website:
www.galderma.com
MediaGaldermaSébastien Cros, +33 1 58 86 45
92media@galderma.com