Teva gets BDP allergy drug NDA accepted by FDA; sued by ViiV over Epzicom

The US Food and Drug Administration has accepted for filing Israeli generics giant Teva Pharmaceutical Industries' (Nasdaq: TEVA) New Drug Application for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA), a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Teva's NDA was submitted to the FDA on May 24, 2011.

BDP Nasal HFA is an investigational intranasal corticosteroid in development for the treatment of allergic rhinitis. The product utilizes the same chemical formulation as Teva’s QVAR (beclomethasone dipropionate HFA) inhalation aerosol, an inhaled corticosteroid approved by the FDA for the maintenance treatment of asthma. BDP Nasal HFA is administered as a non-aqueous solution or "dry spray" delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant.

The latest submission is based on a comprehensive clinical development program including results from two Phase III clinical trials assessing the safety and efficacy of BDP Nasal HFA in the treatment of SAR and PAR. In both trials, BDP Nasal HFA demonstrated significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion versus placebo, said Teva, noting that BDP Nasal HFA was generally well tolerated and the safety profile was similar to that of placebo.