DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced the publication of the long-term data from the MIRROR randomized controlled clinical trial of KRYSTEXXA® (pegloticase) injection with methotrexate, a commonly used immunomodulator, in ACR Open Rheumatology [https://doi.org/10.1002/acr2.11578].
Dec 12 (Reuters) - Amgen Inc (AMGN.O) on Monday agreed to buy Horizon Therapeutics Plc (HZNP.O) in a deal valued at $27.8 billion, fortifying its rare diseases portfolio in the biggest buyout in the sector this year.
Sustained Patient Response to KRYSTEXXA® (pegloticase) Injection with Methotrexate Compared to KRYSTEXXA Alone Shown through Month 12 in MIRROR Randomized Controlled Trial
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data that indicate KRYSTEXXA (pegloticase) injection with weekly oral methotrexate effectively treats uncontrolled gout without compromising kidney function. These findings are presented as part of the American Society of Nephrology (ASN) Kidney Week, Nov. 3-6, 2022.
The label expansion, announced Friday, combines Krystexxa with the chemotherapy and immunosuppressive drug methotrexate. In a randomized trial dubbed Mirror, Horizon demonstrated that patients on the combo responded more favorably compared with those who received a combination of Krystexxa and placebo.
Horizon Pharma Pegloticase Receives Supplemental Approval in US
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of new KRYSTEXXA® (pegloticase injection) datasets on the primary endpoint results from the MIRROR randomized clinical trial and analyses of the pharmacokinetics of KRYSTEXXA plus methotrexate. Additional presentations by Horizon during The EULAR 2022 European Congress of Rheumatology, June 1 – 4 in Copenhagen, include the exploratory findings from the PROTECT trial of KRYSTEXXA with immunomodulation in kidney transplant patients and the impact of chronic gout refractory to conventional therapies (uncontrolled gout).
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) granted priority review of the supplemental Biologics License Application (sBLA) to expand the label for KRYSTEXXA plus methotrexate, an immunomodulator commonly prescribed by rheumatologists. The Prescription Drug User Fee Act (PDUFA) action date is July 7, 2022.
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approved indication for KRYSTEXXA plus methotrexate, an immunomodulator commonly prescribed by rheumatologists.
DUBLIN--(BUSINESS WIRE)--Horizon Therapeutics plc (Nasdaq: HZNP) today announced the presentation of results from the completed PROTECT trial evaluating KRYSTEXXA® (pegloticase injection) in people with chronic gout refractory to conventional therapies, also known as uncontrolled gout, who had received a kidney transplant. In additional presentations, the company shared new insights on the challenges of gout among individuals with chronic kidney disease who undergo dialysis. These data are presented as part of the American Society of Nephrology (ASN) Kidney Week, Nov. 4-7, 2021.