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Teva Receives FDA Approval For First Waterless Nasal Aerosol for Allergic Rhinitis In Young Children טבע הודיעה על קבלת אישור לפורמולציה במינון נמוך יותר של תרסיס לאף לילדים

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) has announced that the U.S. Food and Drug Administration (FDA) approved QNASL® (beclomethasone dipropionate) 40 mcg for treatment of seasonal and year-round nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age. An 80 mcg dose is already available by prescription for adults and children 12 years and older.

QNASL is a nonaqueous, “dry” intranasal corticosteroid (INS) for the treatment of nasal symptoms associated with AR. Corticosteroids are natural substances found in the body that reduce inflammation. The new 40 mcg formulation is the first and only waterless nasal allergy treatment to be approved for use in patients as young as four years of age. The drug is expected to be available by prescription in February 2015.

“The approval of QNASL for use in children aged 4-11 is an important advancement for an often difficult-to-treat patient group,” said Dr. Todd Mahr, MD, Director of Pediatric Allergy and Immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin. “QNASL 40 mcg has several characteristics that provide prescribers with a treatment option specifically designed for children with allergic rhinitis, including its ‘waterless’ aerosol method of delivery and lower dose formulation.”

FDA approval was based on data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL 40 mcg in children (ages 4-11) with allergic rhinitis. Once-daily treatment provided significant nasal allergy symptom relief in children with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in comparison to placebo. In all three studies, the safety profile was similar to placebo and the most common adverse events were nosebleeds and ulcers, consistent with those seen in previous clinical studies of QNASL Nasal Aerosol.

“The approval of this lower dose formulation of QNASL for children reaffirms Teva’s deep-rooted commitment to developing treatment options to help address respiratory conditions among all patient populations,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “Through the availability of QNASL 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies.”

In March 2012, the U.S. Food and Drug Administration (FDA) approved QNASL 80 mcg for adults and children 12 years and older. The product became available by prescription in April 2012, making it the first marketed nonaqueous or “dry-mist” nasal aerosol product in a category that reports annual sales of $2.5 billion. QNASL is delivered as a once-daily, nonaqueous aerosol that uses an environmentally friendly propellant (HFA) and contains a built-in dose counter. In May 2014, the U.S. Food and Drug Administration (FDA) accepted for review the company’s supplemental new drug application (sNDA) for a lower dose QNASL for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age.

 

Allergic Rhinitis
Allergic rhinitis is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, runny nose and nasal congestion. Nasal corticosteroid sprays have been shown to be the most effective treatment for allergic rhinitis. Some people, especially children, may outgrow an allergy as the immune system becomes less sensitive to the trigger, but once a substance causes allergies, it often continues to have a long-term effect.

Teva Pharmaceutical Industries Ltd.
Established in 1901 and headquartered in Israel, 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. 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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