AstraZeneca commences phase III clinical trials of RA drug
30 September 2010 00:00 in Pharmaceutical Company Product News
AstraZeneca has begun a phase III clinical study programme for a potentially promising new oral treatment for rheumatoid arthritis (RA).
The Oskira trial programme will consist of three different studies and will evaluate the safety and efficacy of fostamatinib, a novel oral syk inhibitor, among RA patients who demonstrate an inadequate response to disease-modifying anti-rheumatic drugs.
All three trials will begin with a six-month double-blind, randomised, placebo-controlled phase, with two of them continuing with a further six-month extension period.
It is hoped that AstraZeneca will be able to file for regulatory approval of the drug based on results from these studies in 2013.
Anders Ekblom, AstraZeneca's executive vice-president of global medicines development, said: "We are hopeful that fostamatinib may represent a novel alternative for patients to help manage their condition."
Earlier this month, the company announced that its new thyroid cancer drug vandetanib has been accepted for regulatory review in Europe, following the publication of positive phase III trial data.
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