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 ...
Full story available on Benzinga.com