The US Food and Drug Administration (FDA) will review Israel-based Teva Pharmaceuticals’ supplemental new drug application (sNDA) for a lower dose QNASL nasal aerosol indicated for treatment of seasonal and perennial allergic rhinitis in children aged four to 11 years old.
QNASL (beclomethasone dipropionate) is a waterless intranasal corticosteroid spray currently available only by prescription to treat nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients 12 years and older.
Teva senior vice-president of global respiratory research and development Tushar Shah said: "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 four years of age.
"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 is based on data from three double-blind, placebo-controlled trials that evaluated the safety and efficacy of QNASL in children with allergic rhinitis (AR).
The data showed 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 the trials, the safety profile of QNASL was similar to that of placebo and adverse events were consistent with those seen in previous clinical trials.
University of Colorado Health Sciences Center clinical professor and founder of the William Storms Allergy Clinic William Storms said with about 10% of all children in the US living with allergic rhinitis, there is a need for new treatment options.
"In my practice, I’ve found that identifying the right treatment option for my younger patients can be quite difficult," Storms said.
"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."
According to the company, QNASL when used once a day provides 24-hour relief of nasal allergy symptoms in patients with different types of nasal allergies, such as indoor, outdoor, seasonal and year round.