Novartis' Arcapta Neohaler now available in the U.S. for COPD treatment

Arcapta Neohaler is indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta Neohaler is not indicated to treat asthma. It is also not indicated to treat acute deteriorations of COPD and should not be used as a rescue medication for acute symptoms.

Arcapta Neohaler is the only once-daily, 24-hour long-acting beta2-agonist (LABA) approved in the US for maintenance treatment of airflow obstruction in patients with COPD. Arcapta Neohaler is an inhaled, steroid-free COPD treatment.

Arcapta Neohaler 75 mcg was studied in a total of 641 COPD patients in two key Phase III trials lasting 12 weeks. The primary endpoint results at week 12 showed that Arcapta Neohaler significantly improved lung function (FEV1) at 24 hours compared to placebo. As a secondary endpoint, lung function (FEV1) improvements were seen at five minutes after the first dose compared to placebo, and improvements observed at week 4 were consistently maintained over the course of 12 weeks in both trials.

"Arcapta Neohaler represents an important new treatment option for the 14 million Americans living with COPD," said Andre Wyss, President, Novartis Pharmaceuticals Corporation. "The launch of Arcapta Neohaler is a significant milestone as we continue to establish a strong respiratory presence in the US market."

COPD is a common, preventable and treatable disease characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways of the lungs to noxious particles or gases. More than 14 million people in the US are affected, while another estimated 12 million people are believed to have the disease but remain undiagnosed. COPD ranks as the third leading cause of death in the US and is a major cause of serious long-term disability. Arcapta Neohaler has not been shown to impact mortality or long-term disability caused by COPD.

According to 2011 GOLD Guidelines, bronchodilators are central to COPD management. Bronchodilators have different mechanisms of action and long-acting beta2-agonists (LABA) are among the classes of bronchodilators.

"The COPD Foundation is dedicated to providing information and support individuals with COPD," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "The availability of this new, once-daily LABA is good news for COPD patients looking for new treatment options and for the millions of Americans that are living with this serious disease."

Once-daily Arcapta Neohaler also reduced the need for patients to use short-acting beta2-agonists (albuterol) as rescue therapy, measured as a secondary endpoint. Additionally, Arcapta Neohaler is the only COPD treatment approved with demonstrated improvements in health-related quality of life, as measured by the St George's Respiratory Questionnaire (SGRQ). The SGRQ is a disease-specific, patient-reported instrument that measures health-related quality of life for symptoms, activities and impact of daily life.

The safety and tolerability of Arcapta Neohaler was assessed in a clinical program of more than 5,400 COPD patients, with more than 2,500 who received Arcapta Neohaler for at least 12 weeks at doses of 75 mcg or higher. Adverse reactions were reported by 48% of patients treated with any dose of Arcapta Neohaler compared with 43% of patients treated with placebo. The most common serious adverse reactions were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across treatment groups.

Indacaterol was first approved in November 2009 in the European Union under the brand-name Onbrez® Breezhaler®. It is now approved in more than 80 countries for the treatment of COPD, and is available in more than 30 countries with additional launches planned during 2012.