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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 Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 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 Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 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 Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 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 Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
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 Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
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 transplant.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
The findings indicated that the use of KRYSTEXXA with an immunomodulator may improve persistence to therapy. Approx 90% of the evaluated population met the sUA treatment target and those who received immunomodulation after starting on KRYSTEXXA were less likely to discontinue.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable 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: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2021
Details:
The Prospective Study of Pegloticase in Transplant patients trial is an ongoing Phase 4, open-label trial evaluating the safety and efficacy of KRYSTEXXA in adults with uncontrolled gout who have received a kidney transplant and are on stable immunosuppressive therapy.
Lead Product(s): Pegloticase
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 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: Musculoskeletal Product Name: Krystexxa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 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,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: University of Michigan
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 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 Product Name: PKTX-001
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
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.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2021
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: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
Reducing Immunogenicity of Pegloticase demonstrated that 86.4 percent of patients receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL through Month 3, the primary endpoint of the study.
Lead Product(s): Pegloticase,Mycophenolate Mofetil
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
The real-world usage analysis illustrates that KRYSTEXXA is effectively employed and well-tolerated among dialysis patients. KRYSTEXXA® 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
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Additional studies on the concomitant use of KRYSTEXXA (pegloticase injection) with an immunomodulator to optimize the treatment for people living with chronic gout refractory to conventional therapies (also known as uncontrolled gout) will also be presented.
Lead Product(s): Pegloticase,Mycophenolate Mofetil
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
In the open-label trial, 79 percent of patients who received both KRYSTEXXA and methotrexate (11 of 14 enrolled patients) maintained therapeutic response during Month 6 (defined as sUA <6 mg/dL).
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
Data presentations demonstrate that KRYSTEXXA® (pegloticase injection) can be co-prescribed with three commonly used immunomodulators in rheumatology to potentially help more people with chronic gout refractory to conventional therapies.
Lead Product(s): Pegloticase
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
Details:
Presentations of trial data and in-practice cases will provide results on KRYSTEXXA® (pegloticase injection) with commonly used immunomodulators to help more people with chronic gout refractory to conventional therapies potentially achieve complete response to treatment.
Lead Product(s): Pegloticase
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
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