The U.S. Food and Drug Administration (FDA) has approved Horizon Therapeutics’ (NASDAQ:HZNP) supplemental Biologics License Application (sBLA) for expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, in patients with uncontrolled gout.
The regulatory approval is supported by the results from the MIRROR randomized controlled trial in which adults living with uncontrolled gout showed significant improvement and sustained patient response to KRYSTEXXA with methotrexate compared to KRYSTEXXA alone.
The data readout indicated a greater than 30 percentage-point increase in efficacy, and a significant reduction in infusion reactions from 31percent to 4 percent.
Elizabeth H.Z. Thompson, Executive vice president, research and development, commented : “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. 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.”
The company underscored that uncontrolled gout carries serious, long-term consequences in the joints and throughout the body, as well as a significant impact on a person’s daily life.
Horizon Therapeutics shares closed Thursday’s trading high at $83.61
