Experimental once-a-day asthma drug promising
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An experimental asthma drug under development by Novartis AG works quickly and lasts for 24 hours in patients with asthma and smoker’s lung, data from a study released on Monday showed.
Novartis said its indacaterol drug, formerly known as QAB149, was well-tolerated in patients and worked when administered just once a day, unlike other drugs of its kind which need twice-daily dosing.
“The combination of 24-hour efficacy and a reassuring safety profile suggest that in time, a once-daily dose of indacaterol could become a new standard of care for bronchodilation in asthma and COPD,” said Joerg Reinhardt, Novartis’s head of development.
Chronic obstructive pulmonary disease (COPD), caused primarily by smoking, is the fourth-leading cause of death in the world, affecting about 4 percent of the U.S., European and Japanese population.
Indacaterol is the first once-daily version of a beta2-agonist, a class of drugs that includes treatments by GlaxoSmithKline and Novartis, which have to be taken twice a day, but which have raised concerns about their safety.
Glaxo’s Advair and Serevent, known as salmeterol, carry a “black box” warning on their packaging about one study which showed people taking Serevent had a higher, albeit small, risk of life-threatening asthma attacks and deaths.
An FDA panel has ruled that Novartis’s Foradil, also a beta2-agonist and known as formoterol, should carry a similar warning.
These inhaled drugs are known as long-acting beta agonists and patients take them twice daily to relax bronchial muscles and prevent asthma attacks.
Novartis expects to file the drug for approval in 2007, but analysts at Deutsche Bank noted that respiratory market leader Glaxo was also testing a once-daily drug and planned to combine it with steroids - a commonly prescribed asthma treatment.
The firm also presented data, which showed that its Xolair drug for asthma was safe, well-tolerated and able to maintain stable lung function in studies which lasted more than three years.
Xolair, the first biotech treatment for asthma, has been approved by U.S. regulators but is still awaiting approval in the European Union.
About 300 million people worldwide have asthma, around 15 million of whom suffer from severe persistent asthma, meaning they run a high risk of life-threatening attacks.
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