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Therapeutics","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Rheumatology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Horizon Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Horizon Therapeutics \/ Not Applicable"}]

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01

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

November 08, 2022

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Rheumatology

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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02

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

June 01, 2022

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Rheumatology

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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03

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

May 24, 2022

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Rheumatology

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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04

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

March 07, 2022

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Rheumatology

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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05

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

January 10, 2022

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Rheumatology

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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06

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

November 04, 2021

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Musculoskeletal

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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07

BePharma
Not Confirmed
BePharma
Not Confirmed

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...

Product Name : Krystexxa

Product Type : Large molecule

Upfront Cash : Not Applicable

November 01, 2021

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Musculoskeletal

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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08

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

October 25, 2021

Lead Product(s) : Pegloticase,Methotrexate

Therapeutic Area : Musculoskeletal

Highest Development Status : Phase IV

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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09

BePharma
Not Confirmed
BePharma
Not Confirmed

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 immunosuppr...

Product Name : Krystexxa

Product Type : Large molecule

Upfront Cash : Not Applicable

June 02, 2021

Lead Product(s) : Pegloticase

Therapeutic Area : Musculoskeletal

Highest Development Status : Approved

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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10

BePharma
Not Confirmed
BePharma
Not Confirmed

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 : Large molecule

Upfront Cash : Not Applicable

May 21, 2021

Lead Product(s) : Pegloticase

Therapeutic Area : Musculoskeletal

Highest Development Status : Approved

Sponsor : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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