Shares in AstraZeneca (LON:AZN) have inched higher in London this morning, outperforming the broader market, after the blue-chip company announced that an independent panel of advisers to the US Food and Drug Administration (FDA) had supported the approval of the group’s gout drug lesinurad.
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If approved, it will be for the first time in 60 years that the drug will be used to tackle inefficient excretion in gout patients, said AstraZeneca. In documents released ahead of Friday’s meeting, FDA staff questioned whether the drug’s well-established risks outweigh its benefits.
The AAC elected to favor the drug after assessing its safety and efficiency info throughout the crucial Phase III combination therapy trials.
A majority of the panel for the FDA agreed the benefit of lesinurad was modest, but also meaningful.
AstraZeneca obtained the rights to lesinurad via its acquisition of Ardea Biosciences in June 2012.
Many patients are not able to reach the target levels of uric acid despite using the current treatments creating a need for additional therapies like lesinurad, said Ardea. “We look forward to the outcome of the FDA’s review and the opportunity to provide a new treatment option that when combined with an XOI addresses both the under-excretion and over-production of uric acid, the underlying causes of gout”.
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The current standard of care for gout is an oral drug called allopurinol, which is known to have rare but potentially fatal adverse effects involving skin.
