Teva Announces FDA Acceptance Of SNDA Filing For Pediatric Indication For QNASL® (Beclomethasone Dipropionate) Nasal Aerosol

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.

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