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AstraZeneca's Lesinurad Clears FDA's Arthritis Advisory Committee with Positive Vote

Strategic Insights

— 2 min read

The US Food and Drug Administration's (FDA) Arthritis Advisory Committee (AAC) has voted 10-4 in favor of recommending the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The decision was based on safety and efficacy data from the largest clinical trial data set of gout patients treated with combination urate lowering therapy. Lesinurad, if approved, will be the first selective uric acid reabsorption inhibitor (SURI) in the US, inhibiting the urate transporter, URAT1, responsible for the majority of renal reabsorption of uric acid.

Key Takeaways:

  • The FDA's Arthritis Advisory Committee voted 10-4 in favor of recommending the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).
  • Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that inhibits the urate transporter, URAT1, responsible for the majority of renal reabsorption of uric acid.
  • The decision was based on safety and efficacy data from the largest clinical trial data set of gout patients treated with combination urate lowering therapy.
  • Gout affects millions of Americans, many of whom do not reach recommended serum uric acid (sUA) treatment goals on the current standard of care (XOIs).
  • Lesinurad, if approved, will provide a dual mechanism of action to increase excretion and decrease production of uric acid, enabling more patients with inadequately controlled gout to achieve target treatment goals.
  • The FDA is not bound by the AAC's recommendation but takes its advice into consideration when reviewing the application for lesinurad.
  • Sean Bohen, Executive Vice President of Global Medicines Development and Chief Medical Officer, AstraZeneca, expressed optimism about the Committee's positive recommendation, citing the potential to provide a new treatment option for patients suffering from the debilitating effects of gout.

Statistics:

  • The FDA's Arthritis Advisory Committee voted 10-4 in favor of recommending the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout.
  • Gout affects approximately 8.3 million patients in the US (Source: AstraZeneca).
  • Less than 50% of patients on allopurinol 300 mg reached serum uric acid (sUA) target levels in clinical trials (Source: AstraZeneca).
  • The Prescription Drug User Fee Act (PDUFA) target goal date for lesinurad is December 29, 2015.

Sources:

  • AstraZeneca: "Lesinurad"
  • FDA Law Weekly: "FDA Arthritis Advisory Committee Votes 10-4 in Favor of Lesinurad"
  • BusinessWire: "AstraZeneca's Lesinurad Receives Positive Vote from FDA's Arthritis Advisory Committee"

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