FDA Approves QNASL
Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis
JERUSALEM--(BUSINESS WIRE)--Mar 26, 2012 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) 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 12 years of age and older. The product is expected to be available by prescription in April 2012 and will be the first marketed nonaqueous or “dry” nasal aerosol in a product category that reports annual sales of $2.5 billion.1 QNASLTM is delivered as a once-daily, pressurized, HFA-propelled nonaqueous aerosol that is environmentally friendly2 and offers a built-in dose counter.
“There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies,” said Gary N. Gross, MD, FACAAI, practicing allergist and co-founder of the Dallas Asthma and Allergy Center. “The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery.”
The approval of QNASLTM Nasal Aerosol is based on a comprehensive clinical development program that assessed the product's safety and efficacy in the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adolescent and adult patients 12 years of age and older. The safety and efficacy of QNASLTM Nasal Aerosol was demonstrated in four, Phase III randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials. In these trials, patients received QNASLTM 320 mcg once-daily administered as two sprays in each nostril.
Allergic rhinitis (AR) is the most common allergic disease in the U.S., affecting between 10 to 30 percent of adults and adolescents.3 It affects more than one in five people, causing some to have symptoms year round (PAR) and others to experience symptoms during specific times of the year (SAR), such as spring or fall.4
“Given the number of people living with allergic rhinitis who are still seeking adequate relief, the availability of a new dry nasal aerosol is very welcome news,” said Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America (AAFA). “Seasonal and perennial allergies can have a significant impact on a person's quality of life and we commend Teva for providing patients with a great new option that expands access to quality care.”
While intranasal corticosteroids are recommended as first-line therapy for AR5, the only available options on the market prior to the approval of QNASLTM (beclomethasone dipropionate) were aqueous formulations. Results from a 2010 survey entitled NASAL Allergy Survey Assessing Limitations (NASAL), showed that some nasal allergy patients reported dissatisfaction with their current allergy treatment.6 Healthcare providers and specialists also reported patient dissatisfaction with current nasal sprays.
“The approval of QNASL is a significant milestone for Teva Respiratory and represents our commitment to addressing the unmet needs of millions of Americans suffering from allergic rhinitis,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “We are committed to the development of new options for treatment of respiratory diseases that meet patients' needs.”
About Allergic Rhinitis
Allergic rhinitis (AR) is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. For many AR patients, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom.6 According to a recent survey, patients suffer considerable discomfort during allergy attacks, such that nearly two out of five (38 percent) said their discomfort was not tolerable without relief. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. Morbidity associated with AR can be significant. Effective treatment of AR may improve asthma control when both diseases coexist.
In the U.S., the prevalence of AR has increased during the past three decades; it is recently estimated at 20 percent in the general adult and adolescent populations. Of those Americans affected with AR, approximately 20 percent have SAR, 40 percent have PAR, and 40 percent have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $11.2 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities such as asthma and sinusitis further increase AR-related treatment costs.
About QNASL (beclomethasone dipropionate)
QNASL Nasal Aerosol is a prescription corticosteroid medication that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. It is administered as a nonaqueous or "dry” spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. QNASL Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QNASL Nasal Aerosol is sprayed into the nose, it may help reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing. It is not known if QNASL Nasal Aerosol is safe and effective in children under 12 years of age.
Visit www.qnasl.com/pdf/PI.pdf for full prescribing information.
Important Safety Information
You should avoid using QNASL Nasal Aerosol until your nose is healed if you have a sore in your nose, you have had recent surgery on your nose or if your nose has been injured, because QNASL Nasal Aerosol may cause slow wound healing.
Some people who use corticosteroids may have eye problems such as increased pressure in the eye (glaucoma) or cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use QNASL Nasal Aerosol.
Serious allergic reactions can happen in people taking QNASL Nasal Aerosol. Stop using QNASL Nasal Aerosol and call your healthcare provider right away or get emergency help if you have shortness of breath or trouble breathing, skin rash, redness, swelling, severe itching, or swelling of your lips, tongue or face.
People are more likely to get infections if they use drugs like corticosteroids that may weaken the body's ability to fight infections. Avoid contact with people who have infections like chickenpox or measles. Speak to your doctor before using QNASL Nasal Aerosol if you have tuberculosis or untreated infections of any kind.
A condition in which the adrenal glands do not make enough steroid hormones may occur. Symptoms can include tiredness, weakness, dizziness, nausea and vomiting. Speak to your doctor if you experience these symptoms.
Children taking QNASL Nasal Aerosol should have their growth checked regularly, since corticosteroids may slow growth in children.
The most common side effects with QNASL Nasal Aerosol are nasal discomfort, nosebleeds, and headache.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic version of Protonix® the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone® (including potential generic and oral competition for Copaxone®, the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in our Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission.
1 Allergic Rhinitis Therapeutics – Pipeline Assessment and Market Forecasts to 2018. Retrieved March 9, 2012, from ©Global Data.20: 2011.
2 The Montreal Protocol on Substances that Deplete the Ozone Layer. Retrieved March 12, 2012, from the United Nations Environment Programme. Available at: http://www.unep.org/ozone/pdf/Montreal-Protocol2000.pdf.
3 Rhinitis (Hay Fever): Tips to Remember. Retrieved February 7, 2012, from American Academy of Allergy Asthma & Immunology. Available at: http://www.aaaai.org/conditions-and-treatments/library/at-a-glance/rhinitis.aspx.
4 Hay Fever. Retrieved February 7, 2012, from the Mayo Clinic. Available at: http://www.mayoclinic.com/health/hay-fever/DS00174.
5 Treatment of Allergic Rhinitis. Retrieved March 12, 2012, from the American Family Physician. 2010 Jun 15;81(12):1440-1446.
6 Nasal Allergy Survey Assessing Limitations (NASAL). Retrieved March 13, 2012, Teva Respiratory. Available at: http://www.nasalsurvey.com/.
Contact: Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, 215-591-8912 (United States)
Tomer Amitai, 972 (3) 926-7656 (Israel)
Denise Bradley, 215-591-8974 (United States)
Shir Altay-Hagoel, 972 (3) 926-7590 (Israel)
Posted: March 2012
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