The US Food and Drug Administration (FDA) has accepted Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) application for approval of nasal aerosol corticosteroid for the treatment of seasonal and perennial allergic rhinitis. Teva filed a New Drug Application (NDA) for the drug on the basis of the results of its Phase III safety and efficacy clinical trials of the drug beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA).
In both trials, BDP Nasal HFA demonstrated significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion versus placebo. BDP Nasal HFA was generally well tolerated and the safety profile was similar to that of the placebo.
Teva VP Global Branded Products Prof. Yitzhak Peterburg said, "BDP Nasal HFA has demonstrated promising results in the treatment of both seasonal and perennial allergic rhinitis. We remain committed to addressing unmet needs and dissatisfaction with currently available treatments among the 60 million patients in the US who suffer from allergic rhinitis."
In contrast to current nasal treatments for seasonal and perennial allergic rhinitis, which are delivered by an aqueous or “wet” spray, Teva's treatment is a dry spray, driven by an environmentally friendly aerosol.
Teva's share price fell 1.3% in premarket trading on Nasdaq today to $40.19, giving a market cap of $38 billion, after rising 2.4% by mid-afternoon on the TASE today to NIS 142.40.
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