Novartis receives FDA approval for Arcapta(TM) Neohaler(TM)

NovartisNovartis announced that the US Food and Drug Administration (FDA) has approved once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema[1]. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.

The decision makes Arcapta, formerly known as QAB149, the first once-daily therapy in the long-acting beta2-agonist (LABA) class to be approved in the US for maintenance treatment of airflow obstruction in COPD patients.

"With millions of Americans known to be affected by COPD, the approval of Arcapta is good news for patients," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "A new once-daily medicine is a welcome addition to the treatment options for people suffering with this serious and debilitating disease."

Arcapta 75 mcg was studied in a total of 641 COPD patients in two key Phase III trials lasting 12 weeks. Results at week 12 showed that Arcapta significantly improved lung function at 24 hours compared to placebo[1]. Lung function improvements were seen five minutes after the first dose and consistently maintained over 12 weeks. [1]. Arcapta also significantly reduced the need for patients to use daily rescue medication[1]. Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with the St George's Respiratory Questionnaire (SGRQ) [1]. The SGRQ is widely used in clinical trials to measure symptoms, activities, and impact of COPD on daily life as reported by patients[1].

The clinical trial program supporting US submission evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks at doses of 75 mcg or more[1], with results supporting the safety and tolerability profile of Arcapta. The most common adverse reactions in 449 patients taking Arcapta 75 mcg (i.e. those reported in more than 2% of patients and with higher incidence than placebo) were cough, nasopharyngitis, headache, nausea and oropharyngeal pain.

"Novartis is focused on bringing innovative, safe and effective COPD medicines to patients and physicians," said Trevor Mundel, MD, Global Head of Development in the Pharmaceuticals Division of Novartis. "Indacaterol is the cornerstone of our respiratory portfolio and this US approval represents a significant clinical and regulatory milestone."

Indacaterol was first approved in November 2009 in the European Union under the brand-name Onbrez® Breezhaler®. It is now approved in more than 60 countries for the treatment of COPD, and is available in more than 30 countries with additional launches planned during 2011. The Arcapta US launch is planned for the first quarter of 2012.

COPD is a progressive and life-threatening lung disease that makes it difficult to breathe[4]. More than 12 million people in the US are affected, while another estimated 12 million people are believed to have the disease but remain undiagnosed[2]. COPD ranks as the third leading cause of death in the US[5], [6] and is a major cause of serious long-term disability[3]. Worldwide, COPD is estimated to affect a total of 210 million people[7].

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates and operate in more than 140 countries around the world.

1. Arcapta(TM) Neohaler(TM) PI, Draft, April 24, 2011
2. National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2009 Chart Book on Cardiovascular, Lung, and Blood Diseases. Bethesda, Maryland: U.S Department of Health and Human Services, NIH, NHLBI. October 2009.
3. Sin DD, Stafinski T, NG YC, Bell NR, Jacobs P. The impact of chronic obstructive pulmonary disease on work loss in the United States. Am J Respir Crit Care Med. 2002; 165: 704-707.
4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2009.
5. Minino AM, Xu J, Kochanek KD. Centers for Disease Control, Division of Vital Statistics. Deaths: Preliminary Data for 2008. National Vital Statistics System. December 2010; 59(2).
6. Perez I. New CDC report puts COPD in #3 spot in mortality rates. COPD Foundation. December 9, 2010. http://www.copdfoundation.org/PressRoom/tabid/170/language/en%E2%80%90US/Default.aspx?News=114%00%00. Accessed January 21, 2011.
7. Global Alliance against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 11 May 2011.

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