In the wake of yesterday’s bad news for its cancer compound, PTK/ZK [[28/07/05b]], Swiss giant Novartis has been cheered by a nod from Europe’s regulatory advisory board – the CHMP – recommending approval of its first-in-class compound Xolair (omalizumab) in severe persistent asthma.
Xolair was first approved 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]]. Although it has been hampered somewhat from a narrow indication - for specified patients with moderate to severe asthma - Xolair sales put in an 84% jump during the second quarter for US partner Genentech to $80 million [[12/07/05a]]. A spokesperson for Novartis told PharmaTimes News Online that he believes the drug has established itself in the USA and is highly regarded, and that Xolair still offers blockbuster potential with this new backing in Europe and additional indications being explored.
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 and partner Idenix say that the Phase III registration trial for telbivudine successfully met its primary endpoint of therapeutic response at one year in hepatitis B patients. It is the largest registration trial of its kind, and the firms say they plan to file for US approval by the end of the year. Additional submissions will take place in the first quarter of 2006.