Drugs in Dev. Rheumatology
Phase IV
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : sBLA Submission based on recent results from the MIRROR randomized clinical trial, which showed a 71% response rate for patients randomized to receive KRYSTEXXA (Pegloticase) PEGylated uric acid specific enzyme, plus methotrexate for people living with u...
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
October 01, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The co-administration of KRYSTEXXA (pegloticase) with an immunomodulator like methotrexate has increasingly been employed in patients with uncontrolled gout to help reduce the development of antidrug antibodies, which can affect treatment efficacy with b...
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
August 11, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Application based on recent MIRROR randomized controlled trial results, which showed 71% of patients randomized to receive KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme plus methotrexate achieved a complete response.
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
July 03, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
May 24, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The MIRROR randomized controlled trial outcomes provided a clear view of improvements in patient response and reductions in infusion reactions for KRYSTEXXA plus low-dose (15 mg/week) methotrexate compared to KRYSTEXXA plus placebo.
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
January 06, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Company announced two new KRYSTEXXA development programs: KRYSTEXXA, with methotrexate monthly dosing trial and a KRYSTEXXA retreatment trial evaluating KRYSTEXXA, with methotrexate, in patients who have previously failed KRYSTEXXA.
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
November 01, 2021
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Results show that 71% (71 of 100) of patients who were randomized to receive KRYSTEXXA with methotrexate compared to 40% (21 of 52) of patients who were randomized to receive KRYSTEXXA with placebo achieved the primary endpoint (p<0.001).
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
October 25, 2021
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Mycophenolate Mofetil
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : University of Michigan
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Reducing Immunogenicity of Pegloticase trial showed that 86% of patients receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks vs 40% of patients (4 of 10) receiving KR...
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
July 04, 2021
Lead Product(s) : Pegloticase,Mycophenolate Mofetil
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : University of Michigan
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The results from the completed PROTECT trial (NCT04087720) demonstrated that Krystexxa (Pegloticase & Methotrexate) provide a substantial and sustained decrease in serum uric acid (sUA) for patients with uncontrolled gout who had received a kidney transp...
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
April 11, 2021
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Study Phase : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The current recommended dosing of KRYSTEXXA for adult patients is 8 mg given as intravenous infusions every two weeks, with each dose infused over at least two hours.
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
March 25, 2021
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Reset All
