Promising data for asthma drug, but launch delayed
A trial has shown promising results for the new asthma
drug omalizumab but the United States Food and Drug Administration has
delayed the drug’s approval, asking for more information as it is a new
chemical entity. European regulatory authorities are likely to follow
suit.
The study found that omalizumab (Xolair), an anti-IgE
antibody, is effective and safe in allergic asthma. Dr Markus Solèr, pulmonary
division, University Hospital, Basel, Switzerland, and colleagues conducted
a randomised, double-blind trial in 487 patients (255 received subcutaneous
omalizumab and 232 received placebo). Patients also inhaled beclomethasone,
which was maintained at a constant dose for a 16-week run-in period. After
this stable-steroid phase, the dose of beclomethasone was reduced to the
lowest possible dose required for asthma control.
During the stable-steroid phase, there were 58 per
cent fewer exacerbations per patient in the omalizumab group compared
with the placebo group. In the steroid-reduction phase, there were 52
per cent fewer exacerbations per patient in the omalizumab group. The
proportion of patients who were able to reduce their inhaled corticosteroid
dose by 50 per cent or more was 79 per cent in the omalizumab group and
55 per cent in the placebo group. Corticosteroids were completely withdrawn
in 43 per cent of omalizumab patients and 19 per cent of placebo patients.
Incidence of adverse events was similar between
the groups, although more local injection site reactions were seen in
the omalizumab group compared with the placebo group (11.8 and 7.7 per
cent, respectively). The study is published in this month’s European
Respiratory Journal (2001;18:254).
However, Omalizumab’s expected launch later this
year has been delayed. A spokeswoman for Novartis told The Journal
on 31 July that the FDA had requested more information about the drug
and that this would cause a significant delay to its approval. “We are
assuming that the European Medicines Evaluation Agency will ask for the
same information,” she said. If this is the case, omalizumab is unlikely
to be launched before 2003. The spokeswoman said that there was not a
significant problem with omalizumab but rather the FDA had requested more
information in general because the drug provides a new way of treating
asthma and is a new chemical entity.
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