FDA approves sBLA for Krystexxa
Horizon Therapeutics (Nasdaq: HZNP) has announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) expanding the labeling to include Krystexxa (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy.
“Today’s approval for Krystexxa with methotrexate is the culmination of more than five years of effort and demonstrates Horizon’s commitment to working together with the gout community to improve the patient experience and outcomes,” said Elizabeth Thompson, executive vice president, research and development, Horizon. “Immunomodulatory therapies like methotrexate are often used with biologics to reduce the development of anti-drug a
Clinical backing
Antibodies and allow more patients to achieve a complete response. We anticipate this approval will encourage more physicians to recommend Krystexxa with methotrexate to help their patients with uncontrolled gout receive the full benefits of Krystexxa,” she added.
Horizon gained rights to Krystexxa along with its 2015 acquisition of USA-based Crealta Holdings for $510 million in cash. Crealta itself bought the drug’s originator, Savient Pharmaceuticals, which went into liquidation in 2013.
The expanded labeling for Krystexxa with methotrexate is based on the results from the MIRROR randomized controlled trial in which adults living with uncontrolled gout were randomized to receive methotrexate (15mg/week) or placebo for four weeks, and then treatment with Krystexxa with methotrexate or Krystexxa with placebo for 52 weeks. The primary endpoint was defined as the proportion of serum uric acid (sUA) responders during Month 6 (defined as sUA less than 6 mg/dL at least 80% of the time).
Krystexxa (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
11-07-2022
