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GlaxoSmithKline PLC Sunday said its experimental drug Bosatria has shown in a late-stage trial that it can help control the symptoms of a rare inflammatory condition
LONDON, UK | March 16, 2008 | GlaxoSmithKline PLC Sunday said its experimental drug Bosatria has shown in a late-stage trial that it can help control the symptoms of a rare inflammatory condition.
In the study, significantly more patients with hypereosinophilic syndrome were able to control their disease by taking Bosatria along with a reduced dose of a steroid drug - currently the only treatment option for this condition - when compared with people who received placebo.
Hypereosinophilic syndrome, or HES, is a disorder where very high numbers of eosinophils - the least common white blood cells - are found in the blood, causing inflammation and eventually damage to multiple organs in the body, or even death.
Since no specific treatment for HES is available, patients are given steroids, which help fight inflammation but can also lead to side effects through prolonged use.
The trial, whose results have been published in the New England Journal of Medicine, involved 85 patients. Of those who received Bosatria, 95% maintained eosinophil levels within a normal range for eight weeks or more, compared with 45% who received a placebo, GlaxoSmithKline said.
About 47% were able to gradually reduce the use of steroids for the duration of the 36-week study, compared with 5% of patients who didn't take Bosatria.
The results of the phase-III trial, which was sponsored by the company, were also presented at the American Academy of Asthma, Allergy and Immunology in Philadelphia, Pennsylvania.
GlaxoSmithKline originally developed Bosatria, whose generic name is mepolizumab, for the treatment of allergic asthma and atopic dermatitis.
After mid-stage clinical trials yielded little success, greater promise was found in treating HES, a condition that only affects between 2,000-5,000 patients in the U.S.
As a result, Bosatria has received so-called "orphan" status by regulators in the U.S. and the European Union.
In the U.S., this designation applies to a disease that affects fewer than 200,000 people, while in the E.U. it defines drugs for rare conditions that affect not more than five in 10,000 people.
Phase-III trials are the definitive assessment of a new drug before it is submitted to health regulators for marketing approval.
GlaxoSmithKline expects to apply for marketing approval of Bosatria both in the U.S. and Europe later this year.
SOURCE: GlaxoSmithKline PLC |
