Pegloticase

Biopharmaceutical Giant Amgen to Settle FTC and State Challenges to its Horizon Therapeutics Acquisition

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Sabato, Settembre 2, 2023
Regulations.gov, Amgen, Register, Contract, Commission, CRG, Federal, Pharmacy, Blog, Social media, Federal Trade Commission, Sale, Competition, Graves' ophthalmopathy, District court, Acquisition, Federal Register, Patient, FTC, Compliance, FDA, Douglas v. U.S. District Court ex rel Talk America, News, TED, Generic drug, Health insurance, Fine chemical, Dietary supplement, Cryptocurrency, Pegloticase
Key Points: 

Biopharmaceutical Giant Amgen to Settle FTC and State Challenges to its Horizon Therapeutics Acquisition

Retrieved on: 
Sabato, Settembre 2, 2023
Regulations.gov, Amgen, Register, Contract, Commission, CRG, Federal, Pharmacy, Blog, Social media, Federal Trade Commission, Sale, Competition, Graves' ophthalmopathy, District court, Acquisition, Federal Register, Patient, FTC, Compliance, FDA, Douglas v. U.S. District Court ex rel Talk America, News, TED, Generic drug, Health insurance, Fine chemical, Dietary supplement, Cryptocurrency, Pegloticase

The Federal Trade Commission reached a proposed consent order with Amgen Inc. to address the potential competitive harm that would result from Amgen’s $27.8 billion acquisition of Horizon Therapeutics plc.

Key Points: 
  • The Federal Trade Commission reached a proposed consent order with Amgen Inc. to address the potential competitive harm that would result from Amgen’s $27.8 billion acquisition of Horizon Therapeutics plc.
  • In addition, Amgen may not condition any product rebate or contract terms related to an Amgen product on the sale or positioning either one of these drugs.
  • Under the terms of the consent order, Amgen is required seek FTC such prior approval through 2032 and notify the states if it is seeking Commission approval.
  • The FTC’s proposed consent order, among other conditions, also requires that Amgen:



  • In May 2023, the FTC filed a complaint in the U.S. District Court for the Northern District of Illinois to block the proposed transaction.
  • This was the FTC’s first litigated challenge to a pharmaceutical merger in more than a decade.
  • Further details about the proposed order can be found in the analysis to aid public comment.
  • The FTC will publish the consent agreement package in the Federal Register shortly.

FTC Sues to Block Biopharmaceutical Giant Amgen from Acquisition That Would Entrench Monopoly Drugs Used to Treat Two Serious Illnesses

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Martedì, Maggio 16, 2023
Amgen, Osteoporosis, Commission, Policy, Harm reduction, Blog, History, Social media, Federal Trade Commission, Psoriasis, Competition, Graves' ophthalmopathy, PBM, Acquisition, Patient, FTC, FDA, Memory, News, Autoimmunity, Rheumatoid arthritis, Inflammation, Fine chemical, Pharmaceutical industry, Health insurance, Pegloticase, Etanercept
Key Points: 

FTC Sues to Block Biopharmaceutical Giant Amgen from Acquisition That Would Entrench Monopoly Drugs Used to Treat Two Serious Illnesses

Retrieved on: 
Martedì, Maggio 16, 2023
Amgen, Osteoporosis, Commission, Policy, Harm reduction, Blog, History, Social media, Federal Trade Commission, Psoriasis, Competition, Graves' ophthalmopathy, PBM, Acquisition, Patient, FTC, FDA, Memory, News, Autoimmunity, Rheumatoid arthritis, Inflammation, Fine chemical, Pharmaceutical industry, Health insurance, Pegloticase, Etanercept

The Federal Trade Commission is seeking to block biopharmaceutical giant Amgen Inc. from acquiring Horizon Therapeutics plc, saying the deal would allow Amgen to leverage its portfolio of blockbuster drugs to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout.

Key Points: 
  • The Federal Trade Commission is seeking to block biopharmaceutical giant Amgen Inc. from acquiring Horizon Therapeutics plc, saying the deal would allow Amgen to leverage its portfolio of blockbuster drugs to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout.
  • Neither of these treatments have any competition in the pharmaceutical marketplace.
  • Amgen has for years built its pharmaceutical portfolio through acquisitions, thereby increasing its leverage with the insurers and PBMs that negotiate reimbursement for its products.
  • Amgen has a history of leveraging its broad portfolio of blockbuster drugs to gain advantages over potential rivals.
  • The Commission vote to authorize staff to seek a temporary restraining order and preliminary injunction was 3-0.

Horizon Therapeutics plc Initiates ADVANCE Trial Evaluating KRYSTEXXA® (pegloticase injection) with Methotrexate for People Who Previously Developed Anti-Drug Antibodies on KRYSTEXXA Monotherapy

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Giovedì, Maggio 27, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Clinical medicine, Pegloticase, Gout, Medicine, Rheumatology, KRYSTEXXA, Horizon, KRYSTEXXA, HORIZON

To help maximize treatment options, the ADVANCE trial incorporates insights from current rheumatology practice.

Key Points: 
  • To help maximize treatment options, the ADVANCE trial incorporates insights from current rheumatology practice.
  • ADVANCE is an open-label trial designed to evaluate the efficacy and safety of KRYSTEXXA used with methotrexate for people with uncontrolled gout who previously lost response when treated with KRYSTEXXA monotherapy.
  • KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation.
  • Pegloticase and Methotrexate Co-administered in Patients with Uncontrolled Gout Who Have Previously Failed Pegloticase Monotherapy.

RECIPE Randomized Controlled Trial Data Published in Arthritis & Rheumatology Show Higher Response Rates Using KRYSTEXXA® (pegloticase injection) with the Immunomodulator Mycophenolate Mofetil

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Mercoledì, Aprile 7, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Chemical compounds, Immunosuppressants, Morpholines, Mycophenolic acid, Phenols, Phthalides, Pegloticase, Organic compounds, KRYSTEXXA, Horizon

Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [ doi.org/10.1002/art.41731 ].

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [ doi.org/10.1002/art.41731 ].
  • The safety and efficacy of KRYSTEXXA co-prescribed with mycophenolate mofetil has not been established by any health authorities.
  • During the trial, patients continued to receive either mycophenolate mofetil (1g) twice daily or placebo with KRYSTEXXA for 12 weeks.
  • Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout a Phase II Double Blind Placebo Controlled Randomized Trial.

First Patient Enrolls in FORWARD Trial to Evaluate Monthly Dosing of KRYSTEXXA® (pegloticase injection) and Methotrexate to Treat Uncontrolled Gout

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Giovedì, Marzo 25, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Medical specialties, Health, Medicine, Rheumatology, Uric acid, Inborn errors of purine-pyrimidine metabolism, Gross pathology, Tophus, Gout, Clinical trial, Pegloticase, ULT, KRYSTEXXA, Horizon

"When we successfully treat patients with KRYSTEXXA we can reduce the uric acid levels and resolve tophi.

Key Points: 
  • "When we successfully treat patients with KRYSTEXXA we can reduce the uric acid levels and resolve tophi.
  • The Four-Weekly Administration for Urate Reduction (FORWARD) is an adaptive, staggered-start trial designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of KRYSTEXXA administered monthly (Q4W).
  • In total, the trial aims to enroll up to 30 adults with uncontrolled gout.
  • The FORWARD trial complements our clinical trial assessing shorter-infusion duration options, which enrolled its first patient last fall and continues our efforts to evolve the patient experience with KRYSTEXXA.

Horizon Therapeutics plc Initiates Clinical Trial to Assess Shorter Infusion Duration for KRYSTEXXA® (pegloticase injection) Concomitantly Used with Methotrexate to Treat Uncontrolled Gout

Retrieved on: 
Giovedì, Ottobre 29, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Clinical medicine, Medicine, Immunosuppressants, Pegloticase, Methotrexate, 7+3, Gout, KRYSTEXXA, Horizon

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in the Infusion Duration Study to Assess Tolerability of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate, or AGILE, clinical trial to evaluate a shorter infusion duration for KRYSTEXXA (pegloticase injection) co-prescribed with methotrexate to treat people with chronic gout refractory to conventional therapies, also known as uncontrolled gout.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in the Infusion Duration Study to Assess Tolerability of Pegloticase Administered with a Shorter Infusion Duration in Subjects with Uncontrolled Gout Receiving Methotrexate, or AGILE, clinical trial to evaluate a shorter infusion duration for KRYSTEXXA (pegloticase injection) co-prescribed with methotrexate to treat people with chronic gout refractory to conventional therapies, also known as uncontrolled gout.
  • A shorter infusion duration for KRYSTEXXA could meaningfully impact the experience for patients, clinicians and sites of care.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion.
  • Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate (AGILE).

MIRROR Open-Label Trial Data Published in Journal of Rheumatology Show 79 Percent of Patients Achieved a Complete Response Using KRYSTEXXA® (pegloticase injection) with Methotrexate

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Mercoledì, Settembre 16, 2020
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical trials, Clinical medicine, Medical specialties, Drugs, Immunosuppressants, RTT, Hepatotoxins, Pegloticase, Methotrexate, KRYSTEXXA, Horizon

Patients are randomized to receive methotrexate or placebo for four weeks and then treatment with KRYSTEXXA and methotrexate or KRYSTEXXA and placebo for 52 weeks.

Key Points: 
  • Patients are randomized to receive methotrexate or placebo for four weeks and then treatment with KRYSTEXXA and methotrexate or KRYSTEXXA and placebo for 52 weeks.
  • Caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure, and patients should be monitored closely following infusion.
  • Botson J, Peterson J. Pretreatment and co-administration with methotrexate improved durability of pegloticase response: A prospective, observational, proof-of-concept, case series.
  • Study of KRYSTEXXA (pegloticase) plus methotrexate in patients with uncontrolled gout (MIRROR RCT).

AVISE® MTX Test from Exagen Supports Horizon Therapeutics plc Clinical Trial to Evaluate Pegloticase with Methotrexate to Enhance Response Rates for People Living with Uncontrolled Gout

Retrieved on: 
Giovedì, Ottobre 24, 2019
Medical specialties, Medicine, Clinical medicine, RTT, Arthritis, Immunosuppressants, Gout, Uric acid, Methotrexate, Pegloticase

This study, Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving pegloticase, will enroll approximately 135 subjects to evaluate the use of methotrexate as an immunomodulator to meaningfully attenuate an immune response to pegloticase in adults living with uncontrolled gout.

Key Points: 
  • This study, Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving pegloticase, will enroll approximately 135 subjects to evaluate the use of methotrexate as an immunomodulator to meaningfully attenuate an immune response to pegloticase in adults living with uncontrolled gout.
  • Many biologics have an improved response rate when they are administered together with methotrexate, which reduces the formation of anti-drug antibodies.
  • Exagen cautions you that statements in this press release that are not a description of historical facts are forward-looking statements.
  • The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved.