The European Commission has approved Novartis’ Xolair (omalizumab), an injectable treatment for severe allergic asthma, more than two years after it was given the green light in the USA.

Xolair is the first-ever biological drug to treat asthma – it works by inhibiting immunoglobulin E, an inflammatory mediator that is implicated in allergic reactions – and despite a fairly narrow indication has seen its sales start to take off in the USA [[29/07/05c]]. It is delivered by injection every two to four weeks.

Since its approval in June 2003 in the USA, where it is sold by Genentech, Xolair has seen its turnover grow steadily to reach $80 million in the second quarter of this year, a rise of 84% year-on-year, as clinicians become more comfortable and experienced in its use. Growth slowed somewhat in the third quarter, however, when it brought in $81 million. Genentech maintains that the biologic has blockbuster potential with European approval and additional indications that could broaden its use.

Novartis said the new drug will be available in the first European countries within the next few weeks, and is indicated as an add-on therapy for patients whose asthma symptoms are not controlled despite daily high-dose inhaled corticosteroids plus a long acting inhaled beta2-agonist.

Asthma affects an estimated 30 million people in Europe, with 20% of them suffering from severe asthma. 12,000 deaths are linked to asthma in Western Europe every year.