Switzerland’s Novartis this morning said that its Xolair (omalizumab) drug for severe allergic asthma was safe and effective over a three-year period, adding another boost to its profile in the wake of a European recommendation for approval in July [[29/07/05c]].
Xolair was first cleared in the USA in 2003 and was hailed as the first-ever biological drug to treat asthma, designed to inhibit immunoglobulin E - an inflammatory mediator that is implicated in allergic reactions [[23/06/03b]]. A spokesperson for Novartis recently told PharmaTimes News Online that he believes the drug has established itself in the USA and is highly regarded - a feeling that is likely to be reinforced with these long-term data - and that Xolair does still offer blockbuster potential, with partner Genentech witnessing a more than 80% sales jump during the second quarter of the year [[12/07/05a]].
Results of the 32-week study and three-year follow-up demonstrated that disease control was maintained, with lower than expected changes in lung function and reduced use of inhaled steroids.
Asthma affects an estimated 30 million people in Europe, and around 18% of these are classified as having severe disease. Full approval is anticipated later on this year.
Meanwhile, Novartis has unveiled new data from its investigational once-daily beta2-agonist, indacaterol, showing efficacy over a 24-hour period and a rapid onset of action amongst patients with asthma and chronic obstructive pulmonary disease. “The combination of 24-hour efficacy and a reassuring safety profile suggests 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, Global Head of Development, Novartis. Current beta2-agonists, including Novartis’ Foradil (formoterol) and GlaxoSmithKline’s Serevent (salmeterol), have to be taken twice daily.
The door is wide open for new asthma drugs: the labeling for Serevent, Advair (salmeterol plus fluticasone) and Foradil was strengthened recently to warn of an increased risk of asthma death or a life-threatening experience [[14/07/05a]].