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Drugs in Development
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 uncontrolled Gout.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 01, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : 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
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 biologics.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 11, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sustained Patient Response to KRYSTEXXA® (pegloticase) Injection with Methotrexate Compared to KR...
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
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.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 03, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : 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
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.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 24, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : 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
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.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2022
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Data Presented from the MIRROR Randomized Controlled Trial Demonstrate KRYSTEXXA® (pegloticase in...
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
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.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 01, 2021
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Horizon Therapeutics Provides Update on TEPEZZA® (teprotumumab-trbw) Supply and New KRYSTEXXA® (...
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
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).
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 25, 2021
Lead Product(s) : Pegloticase,Methotrexate
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : 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
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 KRYSTEXXA monotherapy.
Lead Product(s): Pegloticase,Mycophenolate Mofetil
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Phase IVProduct Type: Enzyme
Sponsor: University of Michigan
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2021
Lead Product(s) : Pegloticase,Mycophenolate Mofetil
Therapeutic Area : Rheumatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : 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
Details:
PKTX-001 has shown to significantly improve cell survival and integration into host tissue and will be a valuable asset in the field of regenerative medicine in the future.
Lead Product(s): Pegloticase
Therapeutic Area: Ophthalmology Brand Name: PKTX-001
Study Phase: PreclinicalProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2021
Lead Product(s) : Pegloticase
Therapeutic Area : Ophthalmology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Peer Reviewed Research Paper Reports that ProtoKinetix's AAGP® Enhanced Stem Cell Vision Restorat...
Details : PKTX-001 has shown to significantly improve cell survival and integration into host tissue and will be a valuable asset in the field of regenerative medicine in the future.
Product Name : PKTX-001
Product Type : Enzyme
Upfront Cash : Inapplicable
July 04, 2021
Details:
PROTECT trial evaluating the use of KRYSTEXXA (pegloticase injection) in people with chronic gout refractory to conventional therapies who have received a kidney transplant, as well as pharmacokinetic data regarding the concomitant use of KRYSTEXXA and methotrexate.
Lead Product(s): Pegloticase
Therapeutic Area: Rheumatology Brand Name: Krystexxa
Study Phase: Approved FDFProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 21, 2021
Lead Product(s) : Pegloticase
Therapeutic Area : Rheumatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : PROTECT trial evaluating the use of KRYSTEXXA (pegloticase injection) in people with chronic gout refractory to conventional therapies who have received a kidney transplant, as well as pharmacokinetic data regarding the concomitant use of KRYSTEXXA and m...
Product Name : Krystexxa
Product Type : Enzyme
Upfront Cash : Inapplicable
May 21, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info :
Registration Country : USA
Brand Name : KRYSTEXXA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number : 125293
Regulatory Info :
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Annual Reports
Main Therapeutic Indication : Rheumatology
Currency : USD
2023 Revenue in Millions : 272
2022 Revenue in Millions : 0
Growth (%) : Acquired from Horizon
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
