An advisory committee has recommended that the FDA approve
QAB149 (indacaterol) 75 mcg in the US as a once-daily long-term
maintenance bronchodilator treatment of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis and/or
emphysema.

The committee voted 13 to four in favor of recommending
approval of the 75 mcg dose. The advisory committee also voted 12 to five
against recommending approval of the 150 mcg dose. The 75 mcg dose was seen as
effective as the 150 mcg dose and the committee endorsed the safety of both
doses.

The recommendation by the Pulmonary-Allergy Drug Advisory
Committee (PADAC) followed a request from the FDA to further explore the
efficacy and safety of lower doses of QAB149, an investigational medicine in
the long-acting beta2-agonist (LABA) class.

The FDA has the option of seeking the advice of its advisory
committees when it is reviewing a new drug for approval, although it is not
obliged to follow the committee’s recommendations.

“Novartis is committed to addressing the needs of
patients with COPD and we are encouraged by the advisory committee’s
recommendation for approval of QAB149,” said Trevor Mundel, MD, Global
Head of Development at Novartis Pharma AG. “The company is focused on
bringing innovative, safe and effective treatment options to patients and
physicians, and we will work closely with the FDA as it completes its review of
QAB149.”

The advisory committee reviewed an extensive program of
clinical trials in which the efficacy of QAB149 at 75 and 150 mcg was studied
in a total of 1,282 COPD patients in five key Phase III trials lasting 12-26
weeks. Results showed that both doses of QAB149 significantly improved lung
function compared to placebo. These improvements were seen five minutes after
the first dose and lasted for 24 hours.

The clinical trial program supporting US submission
evaluated safety in 4,764 patients who received QAB149 for at least 12 weeks at
doses of 75 mcg and greater, with results supporting the safety and
tolerability profile of QAB149. The most commonly reported adverse events with
both the 75 and 150 mcg doses were worsening of COPD, nasopharyngitis, cough,
and headache.

“We must intensify our efforts to increase awareness,
prevention and detection, and to develop new treatments to help reduce the
enormous burden COPD places on patients, their families and our healthcare
system,” said John W. Walsh, president and co-founder of the US-based COPD
Foundation. “Deaths from COPD are increasing much faster than previously
projected, which should be a wake-up to all of us.”

QAB149 is approved at 150 and 300 mcg once-daily doses in
more than 50 countries worldwide under the brand-name Onbrez® Breezhaler®.
Altogether, the clinical trial program for QAB149 involved more than 15,000
people of whom 9,243 were given QAB149 at varying doses and assessed for
safety.

In the US,
Novartis is seeking approval for the use of QAB149 as a once-daily long-term
maintenance bronchodilator treatment for airflow obstruction in patients with
COPD, including bronchitis and/or emphysema. Novartis is not seeking an
indication for asthma. If approved in the US, the proposed brand name will be
Arcapta™ Neohaler™.

COPD, a progressive and life-threatening lung disease making
it difficult to breathe, affects more than 12 million people in the US, while
another 12 million people are estimated to have the disease but are
undiagnosed. COPD ranks as the third leading cause of death in the US and is a
major cause of serious long-term disability.