A multinational pharmaceutical company Novartis foretold that the US Food and Drug Administration (FDA) has sanctioned once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg (microgram) for the long-term care bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or pulmonary emphysema. Arcapta isn't indicated for acute deteriorations of COPD or to cover bronchial asthma.
The determination makes Arcapta, formerly called QAB149, the 1st 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 experienced to be affected by COPD, the approval of Arcapta is beneficial news for patients," stated John W. Walsh, president and co-founder of the US-based COPD Foundation. "Afresh once-daily medicine is a welcome improver to the treatment selections for people suffering with this serious and debilitating disease."
Arcapta 75 mcg was analysed in a total of 641 COPD patients in two key phase III clinical trial durable 12 weeks. Results at week 12 bore witness that Arcapta significantly amended lung function at 24 hours equated to placebo. Lung function betterments were seen 5 minutes after the 1st dose and systematically maintained over 12 weeks. . Arcapta as well significantly brought down the need for patients to use daily rescue medication. Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with the St George's Respiratory Questionnaire (SGRQ) . The SGRQ is widely used in clinical trials to measure symptoms, actions, and affect of COPD on daily life as reported by patients.
The clinical trial program supporting US submission evaluated safety in 2,516 patients who found Arcapta for at least 12 weeks at doses of 75 mcg or more, with results supporting the safety and tolerability profile of Arcapta. The basic harmful reactions in 449 patients taking Arcapta 75 mcg (i.e. those accounted in more than 2% of patients and with higher incidence than placebo) were cough, nasopharyngitis, headache, sickness and oropharyngeal pain.
"Novartis is concentrated on adding innovative, safe and effective COPD medicines to patients and medicos," 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 ahttp://www.blogger.com/post-edit.g?blogID=876280343763131026&postID=4281756857749519552pproval represents a significant clinical and regulatory milestone."
Indacaterol was 1st sanctioned in November 2009 in the European Union under the brand-name Onbrez® Breezhaler®. It's now sanctioned 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 beginning quarter of 2012.
COPD is a progressive and dangerous lung disease that makes it difficult to breathe. 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. COPD ranks as the third leading cause of death in the US, and is a major cause of serious long-term disability. Worldwide, COPD is approximated to affect a total of 210 million people.
Source: World Pharma News
The determination makes Arcapta, formerly called QAB149, the 1st 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 experienced to be affected by COPD, the approval of Arcapta is beneficial news for patients," stated John W. Walsh, president and co-founder of the US-based COPD Foundation. "Afresh once-daily medicine is a welcome improver to the treatment selections for people suffering with this serious and debilitating disease."
 |
| Novartis Campus |
Arcapta 75 mcg was analysed in a total of 641 COPD patients in two key phase III clinical trial durable 12 weeks. Results at week 12 bore witness that Arcapta significantly amended lung function at 24 hours equated to placebo. Lung function betterments were seen 5 minutes after the 1st dose and systematically maintained over 12 weeks. . Arcapta as well significantly brought down the need for patients to use daily rescue medication. Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with the St George's Respiratory Questionnaire (SGRQ) . The SGRQ is widely used in clinical trials to measure symptoms, actions, and affect of COPD on daily life as reported by patients.
The clinical trial program supporting US submission evaluated safety in 2,516 patients who found Arcapta for at least 12 weeks at doses of 75 mcg or more, with results supporting the safety and tolerability profile of Arcapta. The basic harmful reactions in 449 patients taking Arcapta 75 mcg (i.e. those accounted in more than 2% of patients and with higher incidence than placebo) were cough, nasopharyngitis, headache, sickness and oropharyngeal pain.
"Novartis is concentrated on adding innovative, safe and effective COPD medicines to patients and medicos," 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 ahttp://www.blogger.com/post-edit.g?blogID=876280343763131026&postID=4281756857749519552pproval represents a significant clinical and regulatory milestone."
Indacaterol was 1st sanctioned in November 2009 in the European Union under the brand-name Onbrez® Breezhaler®. It's now sanctioned 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 beginning quarter of 2012.
COPD is a progressive and dangerous lung disease that makes it difficult to breathe. 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. COPD ranks as the third leading cause of death in the US, and is a major cause of serious long-term disability. Worldwide, COPD is approximated to affect a total of 210 million people.
Source: World Pharma News
0 comments:
Post a Comment