FDA grants priority review of the sBLA for the concomitant use of Krystexxa + methotrexate for people living with uncontrolled gout- Horizon Therapeutics

Krystexxa is indicated for the treatment of chronic gout in adult patients refractory to conventional therapies, also known as uncontrolled gout. As the first and only biologic treatment approved for uncontrolled gout, Krystexxa changed the course of the treatment journey for people living with uncontrolled gout by substantially reducing the physical burden of the disease. Some patients treated with Krystexxa develop anti-drug antibodies, which can limit the effectiveness of treatment. Emerging data has suggested that treatment with Krystexxa in combination with methotrexate can help to prevent these anti-drug antibodies, helping more patients achieve a durable response to therapy.

The sBLA is based on the MIRROR randomized controlled trial (Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving KRYSTEXXA trial), which showed 71.0% of patients (71 of 100) who were randomized to receive Krystexxa plus methotrexate achieved a complete serum uric acid (sUA) response, defined as sUA <6 mg dl at least 80% of the time during month 6. the trial demonstrated a 32.5-percentage point improvement compared to those randomized to krystexxa with placebo (38.5%; 20 of 52 patients) (p><0.0001). no new safety concerns were identified.these results reinforce what has been published in multiple case series, as well as the mirror open-label trial, showing improved treatment response rates through the use of krystexxa plus methotrexate.-.></0.0001).></6>