Novartis’ indacaterol (QAB149) to treat COPD needs more data on dosing: US FDA

Indacaterol (QAB149) has already received a positive regulatory opinion in Europe

Indacaterol (QAB149), a drug to treat chronic obstructive pulmonary disease (COPD), from Novartis has been delayed for approval in US, pending more data on dosing.

US Food and Drug Administration (FDA) has requested additional information on dosing proposed for indacaterol (QAB149), Novartis said in a press statement on receiving Complete Response letter from the regulatory agency.

Indacaterol (QAB149), a long-acting beta2-agonist (LABA), is an investigational once-daily bronchodilator for the treatment of adult patients with chronic obstructive pulmonary disease (COPD).

Indacaterol (QAB149) was submitted for US regulatory approval in December 2008 as a new once-daily bronchodilator for maintenance treatment of airflow obstruction in patients with COPD.

The submission for indacaterol (QAB149) was based on a Phase III clinical trial program with three pivotal studies and enrolled 4,400 patients with moderate-to-severe COPD.

Indacaterol (QAB149) initial results from three pivotal phase III trials released in May showed the  investigational bronchodilator  could deliver clinically relevant lung function improvements, within five minutes of the first dose, lasting for 24 hours in patients with chronic obstructive pulmonary disease (COPD).

The data presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego also showed that indacaterol (QAB149) significantly improved lung function from the first day of therapy to up to one year of treatment.

Indacaterol (QAB149) data also revealed that all evaluated doses of QAB149 were well-tolerated and had a good overall safety profile.

All doses of once-daily QAB149 met the primary efficacy endpoint of significant improvement in FEV1 (forced expiratory volume in one second) versus placebo at twelve weeks. This improvement was seen as early as five minutes post-dose and at every subsequent time point measured in each study.

Indacaterol (QAB149) has received positive opinion in Europe from the Committee for Medicinal Products for Human Use (CHMP) in September 2009 supporting regulatory approval of the drug as a once-daily therapy with two doses (150 micrograms and 300 micrograms). The European Commission generally follows the recommendations of the CHMP, which is the scientific committee of the European Medicines Agency.

What is COPD?

Chronic obstructive pulmonary disease (COPD) is a progressive, life-threatening respiratory disease that affects 210 million people around the world. Cigarette smoke and other harmful fumes can cause COPD. COPD is characterized by a persistent obstruction of airflow in the lungs, resulting in breathlessness.

According to the World Health Organization, COPD is currently projected to become the third leading cause of death worldwide by 2030.

Bronchodilators are a group of drugs that widen the airways in the lungs. While COPD is incurable, improving airflow with the use of long-acting bronchodilators is key to symptomatic management

Headquartered in Basel, Switzerland, Novartis AG offers a diversified portfolio of innovative medicines, generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. Novartis Group posted net sales of USD 41.5 billion and net income of USD 8.2 billion, in 2008.