GlaxoSmithKline says Bosatria phase III study results 'significant'
LONDON (Thomson Financial) - British drugmaker GlaxoSmithKline (LSE: GSK.L - news) has announced that significantly more patients who were given Bosatria, its new treatment against hypereosinophilic syndrome (HES), were able to control their disease with a reduced dose of a corticosteroid compared with those who were given a placebo.
The Phase III study, published in the New England Journal of Medicine, showed that patients need a reduced level of corticosteroids when taking Bosatria, which is based on the active ingredient mepolizumab.
This is significant because prolonged use of corticosteroids, which are prescribed off-label, often causes serious side-effects.
In a post-hoc analysis, nearly half (47 pct) of patients treated with mepolizumab tapered off corticosteroids completely and remained steroid-free through the completion of the study, compared to 5 pct of patients treated with a placebo, Glaxo said.
HES is a group of rare disorders characterised by persistent elevated levels of white blood cells in the blood and tissues leading to respiratory, cardiac, skin and gastrointestinal problems and can be fatal in some people with advanced cases of the disease.
Yvonne Greenstreet, senior vice-president of the company's musculoskeletal, inflammation, gastrointestinal and urology medicine development centre, said: 'This study demonstrates that mepolizumab, if approved by regulators, may provide physicians with a new therapeutic option to provide disease control while reducing corticosteroid use in HES patients.' |
