GSK expands its portfolio of medicines in the US for patients with asthma and COPD

Arnuity™ Ellipta® now available in the US for once-daily treatment of asthma. Incruse® Ellipta® now available in the US for once-daily treatment for COPD.

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the simultaneous availability of two of its recently approved products for the treatment of asthma and COPD to retail pharmacies in the US. Over the past 15 months, GSK has launched four inhaled respiratory therapies in the US, all delivered in its Ellipta® inhaler.

Arnuity™ Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid (ICS) medicine for the maintenance treatment of asthma. It is the first product in the Ellipta inhaler for the treatment of asthma to be introduced in the US.

Arnuity Ellipta is indicated for once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity Ellipta is not indicated for the relief of acute bronchospasm. It acts to reduce inflammation associated with asthma and helps to prevent and control the symptoms of asthma.

Arnuity Ellipta is available in two approved doses, 100mcg and 200mcg.

GSK also announced today that Incruse® Ellipta® (umeclidinium bromide), an anticholinergic indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, is now available to retail pharmacies in the US. Incruse is GSK's first anticholinergic monotherapy, a type of bronchodilator that can relax airway smooth muscles and improve airflow in and out of the lungs. Incruse Ellipta is available as 62.5 mcg of umeclidinium dry inhalation powder, administered once-daily using the Ellipta inhaler.

"We're excited to share this news with patients. Forty years after the launch of our first respiratory therapy, we remain committed to innovation and helping a wide range of appropriate patients. These are the third and fourth respiratory products we've introduced since October 2013 in our patented Ellipta inhaler," said Jorge Bartolome, Senior Vice President of the GSK Respiratory Business Unit in the US. "The Ellipta allows for a common inhaler platform across our inhaled therapies approved since 2013."

GSK has made available a new "FREE to you for 12 months" coupon for Incruse Ellipta and Arnuity Ellipta. The savings offer coupon will pay the entire out-of-pocket (OOP) cost for eligible commercial and cash patients for up to twelve months. (Eligibility and other limitations apply.) This new "FREE to you for 12 months" savings offer is also available with some of our other GSK products. For more information, visit www.gskforyou.com.

Full U.S. Prescribing Information, including Patient Information Leaflets, is available at us.gsk.com. For images of Arnuity Ellipta and Incruse Ellipta, please see our press kit.

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways.1 Approximately 26 million people in the USA currently have asthma.2 Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.3

The causes of asthma are not completely understood but likely involve an interaction between a person's genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

About COPD

COPD is a common, preventable and progressive disease, which includes a range of conditions that limit airflow to the lung. COPD is characterized by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the US alone are affected by COPD4.

According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. In the United States, the most common irritant that causes COPD is cigarette smoke. Breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

Important Safety Information for Arnuity Ellipta

The following Important Safety Information is based on the Highlights section of the Prescribing Information for Arnuity Ellipta. Please consult the full Prescribing Information for all the labelled safety information for Arnuity Ellipta.

Arnuity Ellipta is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any ingredients of Arnuity Ellipta.

Candida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta.

Do not use Arnuity Ellipta for the relief of acute symptoms.

Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.

Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Arnuity Ellipta.

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.

Discontinue Arnuity Ellipta and institute alternative therapy if paradoxical bronchospasm occurs.

Monitor patients with major risk factors for decreased bone mineral content.

Monitor growth of adolescent patients.

Close monitoring for glaucoma and cataracts is warranted.

The most common adverse reactions (reported in greater than or equal to 5% of subjects) with Arnuity Ellipta were upper respiratory tract infection, nasopharyngitis, headache, and bronchitis.

Use Arnuity Ellipta with caution in patients taking strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole) because this may cause systemic corticosteroid effects.

Fluticasone furoate exposure may increase in patients with moderate or severe hepatic impairment. Monitor for systemic corticosteroid effects.

Important Safety Information for Incruse Ellipta

The following Important Safety Information is based on the Highlights section of the Prescribing Information for Incruse Ellipta. Please consult the full Prescribing Information for all the labelled safety information for Incruse Ellipta.

Incruse Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to umeclidinium, or any of the other ingredients.

Incruse Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm, which should be treated with an inhaled, short-acting beta2-agonist.

Incruse Ellipta can produce paradoxical bronchospasm, which may be life-threatening.

Incruse Ellipta should be used with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately should any signs or symptoms of narrow-angle glaucoma occur.

Incruse Ellipta should be used with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder neck obstruction. Instruct patients to contact a physician immediately should any signs or symptoms of urinary retention occur.

The most common adverse reactions (incidence ≥2% and more common than placebo) with Incruse Ellipta (and placebo) were nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); cough, 3% (2%); and arthralgia, 2% (1%). Other adverse reactions with Incruse Ellipta observed with an incidence less than 1% but more common than placebo included atrial fibrillation.

Avoid co-administration of Incruse Ellipta with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects such as worsening of narrow-angle glaucoma, and worsening of urinary retention.

Arnuity™ is a trademark and Incruse® and Ellipta® are registered trademarks of the GSK group of companies.

GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

References
1. Global Initiative for Asthma. Pocket Guide for asthma management and prevention. Updated 2014.
2. American Lung Association, Epidemiology and Statistics Unit, Research and Program Services Division, Trends in Asthma Morbidity and Mortality, September 2012, www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf
3. Demoly et al. Eur Respir Rev. 2012 Mar 1; 21(123):66-74. doi: 10.1183/09059180.00008111.
4. National Heart, Lung, and Blood Institute. 2012 Chart Book on Cardiovascular, Lung, and Blood Diseases. February 2012, http://www.nhlbi.nih.gov/resources/docs/2012_ChartBook_508.pdf

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