All 10 supporters of the drug, lesinurad, passed their voting by compelling the FDA to ask AstraZeneca for studies after lesinurad launch to measure its long-lasting effectiveness and safety.
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The company said that gout is a serious, as well as, unbearable inflammatory arthritis form caused by hyperuricemia.
The recommendation follows comments from the FDA’s staff on Wednesday, which raised questions about the drug’s benefit-risk profile, pointing specifically to increased cardiovascular and renal risks.
Even so, the committee voted 10:4 in favour of approval and with gout affecting more than 8mln people in the USA, sales of the new drug may top US$220mln by 2018. Uric acid crystals form deposits in the joints which leads to inflammation. However, the results were not a home run, with the combination failing to show a significant improvement on a few outcome measures and a sizable block of test subjects failing to reach target uric acid levels. Lesinurad works by inhibiting re-absorption of uric acid in the kidneys, increasing uric acid excretion.
Another recent entrant into the market – Savient Pharmaceuticals – was unable to make headway with its Krystexxa (pegloticase) therapy and was forced to file for bankruptcy in 2013.
AstraZeneca obtained the rights to lesinurad via its acquisition of Ardea Biosciences in June 2012.
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AstraZeneca said, if approved, lesinurad will be the first in 60 years to address inefficient excretion in gout patients. The company is now looking forward to the next stage of the decision from the FDA to offer a fresh option of treatment.
