FONT-SIZE Plus   Neg

Teva Wins FDA Approval For Qnasl Nasal Aerosol To Treat Allergic Rhinitis


Generic drugmaker Teva Pharmaceutical Industries Ltd. (TEVA) on Monday said the U.S. Food and Drug Administration has approved Qnasl Nasal Aerosol, a new, dry nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents who are 12 years old or above.

The approval was based on a comprehensive clinical development program that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years of age and older.

Allergic rhinitis is the most common allergic disease in the U.S. It affects more than one in five people, causing some to have symptoms year round and others to experience symptoms during specific times of the year.

The safety and efficacy of Qnasl Nasal Aerosol was demonstrated in four, Phase III trials, where patients received Qnasl 320 mcg once-daily administered as two sprays in each nostril.

Intra-nasal corticosteroids are recommended as first-line therapy for allergic rhinitis and the only available option on the market before the approval of Qnasl (beclomethasone dipropionate) were aqueous formulations.

The product is expected to be available by prescription in April. It will be the first marketed non-aqueous or dry nasal aerosol in a product category that reports annual sales of $2.5 billion.

Qnasl is delivered as a once-daily, pressurized, hydrofluoroalkane or HFA-propelled non-aqueous aerosol that is environmentally friendly and offers a built-in dose counter.

Gary Gross, practicing allergist and co-founder of the Dallas Asthma and Allergy Center, said, "There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies. The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery."

Teva shares, which closed at $43.07 on Friday, are adding 2.1 percent in pre-market activity.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Swiss drug giant Novartis AG reported Tuesday higher net profit in its third quarter, while sales were weak due to generic competition and pricing. Core earnings per share topped analysts' estimates, but sales missed their view. For fiscal 2016, the company continues to expect Core operating income to be broadly in line or decline low-single digit, and net sales to be broadly in line.. Social media site Twitter Inc., which is facing an uncertain future, is planning to cut around 8 percent of its total workforce, Bloomberg reported Monday citing people familiar with the matter. The company, which is trying cost control amid slowing sales growth, may announce the job cut of about 300 people as soon as this week. Visa Inc. (V) on Monday reported an increase in profit for the fourth quarter, as revenues jumped driven largely by increase in customer spending and inclusion of Europe business. Earnings and revenues trumped Wall Street expectations. Foster City, California-based Visa's fourth-quarter profit rose...
comments powered by Disqus
Follow RTT