AstraZeneca’s (LON:AZN) treatment for gout, lesinurad, has received an approval recommendation from the athritis committee of US regulator the Food and Drug Administration.
The advisory committee has recommended 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.
While the FDA does not have to take the recommendation of a committee, the advice is often accepted though UBS suggested the call may closer this time.
Market expectations for the drug are low said the broker because of comparatively modest efficacy for the safer lower 200mg dose while there was renal toxicity in the higher 400mg dose.
FDA briefing documents focused on safety - especially on the potentially narrow therapeutic window. The uncertainty seemed to revolve around where the cut off for renal impairment should be, said the broker.
Even so, the committee voted 10:4 in favour of approval and with gout affecting more than 8mln people in the US, sales of the new drug may top US$220mln by 2018.
Hyperuricemia, where an excess of uric acid leads to crystals forming around the joints, causes the disease. Lesinurad inhibits re-absorption of uric acid in the kidneys, increasing uric acid excretion, said AstraZeneca.
UBS said possible outcomes still include the FDA seeking more safety reassurance prior to approval or label restrictions for renally impaired patients, though overall the news as a small positive.
Astra shares rose 10p to 4,080p.