FDA Approves Teva's QNASL For Pediatric Patients With Allergic Rhinitis
By Cyndi Root
Teva Pharmaceutical has a new allergy treatment for children as young as four years old. The company announced in a press release that the Food and Drug Administration (FDA) has approved QNASL (beclomethasone dipropionate) to treat the nasal symptoms associated with allergies in children ages 4 to 11 years of age. Tushar Shah, MD, SVP at Teva Global Respiratory Research and Development, said, “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.”
QNASL
QNASL’s first approval in March 2012 was for adults and adolescents 12 years of age and older for the treatment of seasonal nasal and year-round nasal allergy symptoms. The FDA accepted Teva’s supplemental New Drug Application (sNDA) for the pediatric indication in May 2014. QNASL’s active ingredient is beclomethasone, a synthetic corticosteroid. The agent works to limit inflammation in the nasal passages that causes stuffy nose, runny nose, nasal itching, and sneezing. The drug is delivered in a waterless aerosol intranasal spray, via a propellant, hydrofluoroalkane (HFA). The dose for children is 40 mcg in contrast to the 80 mcg prescribed for people over the age of 12. Teva states that QNASL will be available for pediatric patients in February 2015.
FDA Action
Teva announced in November 2014 that Phase 3 studies of QNASL in pediatric patients showed efficacy and provided a basis for FDA approval. One Phase 3 study lasted 12 weeks and included 547 patients in a placebo-controlled trial. Patients were administered a dose or actuation in each nostril. Investigators measured symptoms using morning and evening symptom scores at 6 and 12 weeks. QNASL patients showed significant improvement in symptoms compared to the placebo group. The agent was well-tolerated and considered safe.
In taking its approval action, the FDA considered data from other trials that showed significant reduction in nasal allergy symptoms in patients with seasonal allergic rhinitis (SAR) and those with perennial allergic rhinitis (PAR). Teva states that adverse events were comparable to the placebo group, with the most common side effects being nosebleeds and ulcers, consistent with other studies of the waterless aerosol.