First waterless corticosteroid nasal spray to apply for pediatric
approval
JERUSALEM--(BUSINESS WIRE)--May 13, 2014--
Teva Pharmaceuticals Industries Ltd., (NYSE:TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for review the
company’s supplemental new drug application (sNDA) for a lower dose QNASL®
(beclomethasone dipropionate) Nasal Aerosol for the treatment of
seasonal and perennial allergic rhinitis in children 4-11 years of age.
QNASL is a waterless intranasal corticosteroid spray currently available
for the treatment of nasal symptoms of seasonal allergic rhinitis (SAR)
and perennial allergic rhinitis (PAR) in patients 12 years of age and
older.
“We are very pleased the FDA has accepted for review the sNDA for QNASL®.
If the FDA approves the new indication for QNASL®, it
will become the first waterless HFA nasal allergy treatment approved for
patients as young as 4 years of age,” said Tushar Shah, MD, Senior Vice
President, Teva Global Respiratory Research and Development. “The
low-dose formulation demonstrates our commitment to the development of
innovative treatment options for all patients with respiratory
conditions, including nasal allergies.”
The sNDA filing includes data from three double-blind,
placebo-controlled studies that evaluated the safety and efficacy of
QNASL® in children with allergic rhinitis (AR). The
data demonstrated that once-daily treatment with QNASL®
provided significant nasal allergy symptom relief in pediatric subjects
with SAR and PAR when compared with placebo. In all three studies the
safety profile of QNASL® was similar to that of
placebo and adverse events were consistent with those seen in previous
clinical studies.
“With approximately 10 percent of all children in the U.S. living with
allergic rhinitis, there is a need for new treatment options that can
help children and their caregivers better manage the often bothersome
symptoms of nasal allergies,” said Dr. William Storms, MD, practicing
allergist, clinical professor at the University of Colorado Health
Sciences Center and founder of the William Storms Allergy Clinic in
Colorado Springs, CO. “In my practice, I’ve found that identifying the
right treatment option for my younger patients can be quite difficult.
That’s why the potential to offer a safe and effective waterless
treatment option, such as QNASL®, may prove to be an
exciting new prospect for many practicing allergists treating pediatric
allergy patients.”
QNASL® is a waterless nasal allergy aerosol available
only by prescription. When used once a day, QNASL®
delivers 24-hour relief of nasal allergy symptoms in patients with
different types of nasal allergies, such as indoor, outdoor, seasonal
and year round.
About Allergic Rhinitis
Allergic rhinitis is a chronic inflammatory disease characterized by
symptoms such as sneezing, nasal itch, runny nose and nasal congestion.
For many AR patients, nasal congestion or a stuffy nose may be the most
frequent and bothersome symptom. According to a recent survey, patients
suffer considerable discomfort during allergy attacks, such that nearly
two out of five (38 percent) said their discomfort was not tolerable
without relief. Based on the available evidence, intranasal
corticosteroids are the most effective treatment options for patients
with AR.
According to the American Academy of Allergy, Asthma and Immunology
(AAAAI), the prevalence of AR in the U.S. has increased during the past
three decades; it is recently estimated at 20 percent in the general
adult and adolescent populations. Of those Americans affected with AR,
approximately 20 percent have SAR, 40 percent have perennial allergic
rhinitis (PAR) and 40 percent have a combination of the two (i.e., PAR
with seasonal exacerbation) depending on the allergen sensitivity.
Because of its prevalence and health effect, AR is associated with
considerable direct and indirect costs. An estimate of $11.2 billion in
healthcare costs, 12 million physician office visits, 2 million days of
school absences and 3.5 million lost work days per year are attributed
to AR. In addition, the presence of co-morbidities such as asthma and
sinusitis further increase AR-related treatment costs.
About QNASL® (Beclomethasone Dipropionate)
QNASL® (beclomethasone diproprionate) Nasal Aerosol is a
prescription corticosteroid medication that treats nasal symptoms
associated with seasonal and year-round allergies in adults and
adolescents 12 years of age and older. It is administered as a waterless
spray delivered by hydrofluoroalkane (HFA), an environmentally friendly
propellant. QNASL® contains beclomethasone dipropionate,
which is a man-made (synthetic) corticosteroid. Corticosteroids are
natural substances found in the body that reduce inflammation. When QNASL®
is sprayed into the nose, it helps reduce the nasal symptoms of allergic
rhinitis (inflammation of the lining of the nose), such as stuffy nose,
runny nose, nasal itching and sneezing.
Important Safety Information
In clinical studies, nosebleeds and nose ulcers were more common in
patients treated with QNASL® Nasal Aerosol than patients who
received placebo. Some nosebleeds were more severe in patients treated
with QNASL® Nasal Aerosol than in patients who received
placebo. Tell your healthcare provider if you start to have nosebleeds
or nasal ulcers after using QNASL® Nasal Aerosol.
Thrush (Candida), a fungal infection in your nose, mouth, or
throat may occur. Tell your healthcare provider if you have any redness
or white colored patches in your mouth or throat.
You should avoid using QNASL® Nasal Aerosol until your nose
is healed if you have a sore in your nose, you have had recent surgery
on your nose or if your nose has been injured, because QNASL®
Nasal Aerosol may cause slow wound healing.
Some people who use corticosteroids may have eye problems such as
increased pressure in the eye (glaucoma) or cataracts. If you have a
history of glaucoma or cataracts or have a family history of eye
problems, you should have regular eye exams while you use QNASL®
Nasal Aerosol.
Serious allergic reactions can happen in people taking QNASL®
Nasal Aerosol. Stop using QNASL® Nasal Aerosol and call your
healthcare provider right away or get emergency help if you experience
shortness of breath or trouble breathing, skin rash, redness, swelling,
severe itching, or swelling of your lips, tongue or face.
People are more likely to get infections if they have immune system
problems or use drugs, including corticosteroids, which may weaken the
body’s ability to fight infections. Avoid contact with people who have
infections like chickenpox or measles while using QNASL®
Nasal Aerosol.
Speak to your healthcare provider before using QNASL® Nasal
Aerosol if you have tuberculosis or untreated fungal, bacterial, or
viral infections, or eye infections caused by herpes. Symptoms of an
infection include: fever, pain, aches, chills, feeling tired, nausea and
vomiting.
A condition in which the adrenal glands do not make enough steroid
hormones may occur. Symptoms can include tiredness, weakness, dizziness,
nausea and vomiting. Tell your healthcare provider if you experience
these symptoms.
Children taking QNASL® (beclomethasone dipropionate) Nasal
Aerosol should have their growth checked regularly, since
corticosteroids may slow growth in children.
The most common side effects with QNASL® Nasal Aerosol are
nasal discomfort, nosebleeds and headache.
Tell your healthcare provider if you have any side effect that bothers
you or that does not go away.
These are not all of the possible side effects of QNASL®
(beclomethasone dipropionate) Nasal Aerosol. For more information, ask
your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Visit http://qnasl.com/Content/pdf/pi.pdf
for full prescribing information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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Source: Teva Pharmaceuticals Industries Ltd.
Teva Pharmaceuticals Industries Ltd.
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