Hyaluronidase (human recombinant)
- Generic Name
- Hyaluronidase (human recombinant)
- Brand Names
- Darzalex Faspro, Herceptin Hylecta, Hylenex, Hyqvia 5 G / 50 Ml Kit, Phesgo, Rituxan Hycela, Vyvgart Hytrulo
- Drug Type
- Biotech
- CAS Number
- 757971-58-7
- Unique Ingredient Identifier
- 743QUY4VD8
- Background
A purified preparation of the enzyme recombinant human hyaluronidase. Hyaluronidase (human recombinant) (INN Vorhyaluronidase alfa) is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents. The action of hyaluronidase was first described in 1936, and named in 1939. Early research into hyaluronidase identified it as a "spreading factor" which allowed for increased permeability of the connective tissue. Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics.
Hyaluronidase was first used in prescription products in the United States on 5 May 2004.
- Indication
Hyaluronidase is indicated for subcutaneous fluid administration for hydration, and increasing resorption of radiopaque agents in subcutaneous urography. Hyaluronidase is also indicated by multiple routes to increase the dispersion of other injectable drugs.
- Associated Conditions
- Drug Extravasation, Generalized Myasthenia Gravis, Inflammatory Breast Cancer (IBC), Locally Advanced Breast Cancer (LABC), Metastatic Breast Cancer, Primary Immune Deficiency Disorders (PIDD), Primary Immunodeficiency, Secondary humoral immunodeficiency, Stage I Breast Cancer
- Associated Therapies
- Parenteral rehydration therapy, Improving resorption of radiopaque agents, To increase percutaneous drug absorption therapy
FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma
• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
• The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
• Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.
FDA Advisory Committee Rejects Genentech's Columvi Expansion for Transplant-Ineligible DLBCL Patients
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against expanding Genentech's bispecific antibody Columvi for transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
• Committee members expressed concerns about the applicability of the Phase III STARGLO study data to the U.S. population, as half of the participants were Asian patients with only 25 enrolled from North America.
• Columvi, which targets CD20 and CD3 proteins, was initially approved in June 2023 for DLBCL patients who had undergone at least two prior lines of systemic therapy.
Riliprubart Shows Promise in CIDP Treatment with Significant Neurofilament Light Reduction
• Phase 2 study results reveal that Sanofi's investigational riliprubart reduced plasma neurofilament light levels by 31% in patients with chronic inflammatory demyelinating polyneuropathy.
• Greater reductions in neurofilament light levels correlated with higher treatment response rates, with up to 69% of patients showing improvement in disability scores.
• Riliprubart, a selective inhibitor of the classical complement pathway, is now being evaluated in two global Phase 3 trials (MOBILIZE and VITALIZE) across 28 countries.
Ten-Year APHINITY Data Shows Perjeta-Based Regimen Reduces Death Risk by 17% in HER2-Positive Early Breast Cancer
• Long-term follow-up data from the Phase III APHINITY trial demonstrates a statistically significant 17% reduction in risk of death when adding Perjeta (pertuzumab) to Herceptin (trastuzumab) and chemotherapy in early-stage HER2-positive breast cancer.
• The benefit was more pronounced in patients with lymph node-positive disease, showing a 21% reduction in death risk, reinforcing the regimen's value as a standard-of-care treatment in the curative setting.
• After ten years, 91.6% of patients receiving the Perjeta-based regimen were alive compared to 89.8% in the control group, with the previously reported invasive disease-free survival benefit maintained without new safety concerns.
Takeda Spotlights Three Late-Stage Readouts as Potential "Inflection Point" Amid Vyvanse Generic Competition
• Takeda Pharmaceutical is positioning three upcoming late-stage clinical trial readouts as a strategic "inflection point" to offset revenue losses from Vyvanse's generic competition.
• The Japanese pharmaceutical giant is focusing on new product launches and pipeline advancement to maintain growth momentum, with particular emphasis on rare disease and neuroscience therapeutic areas.
• Industry analysts view Takeda's pipeline strategy as critical for the company's long-term financial stability, as it navigates the challenging transition period of losing exclusivity for one of its top-selling medications.
FDA Approves Pre-Filled Syringe for Self-Injection of Efgartigimod in gMG and CIDP Patients
• The FDA has approved a new pre-filled syringe formulation of efgartigimod (VYVGART Hytrulo) for self-injection in adults with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
• The self-injection option provides patients greater independence and flexibility, allowing treatment at home or while traveling, reducing the need for frequent clinic visits while maintaining the medication's established safety and efficacy profile.
• Developed through argenx's partnership with Halozyme's ENHANZE drug delivery technology, the pre-filled syringe enables rapid 20-30 second subcutaneous administration, with regulatory decisions expected in the EU, Japan, and Canada by 2025.
CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025
• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.
• AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics.
• Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.
Roche's OCREVUS Shows Strong Efficacy in MUSETTE Phase III Trial for Multiple Sclerosis
• Roche Holding's MUSETTE Phase III trial demonstrated strong efficacy of the approved 600 mg dose of OCREVUS for multiple sclerosis, reinforcing its position in the treatment landscape.
• The company has launched a new subcutaneous formulation of OCREVUS, expanding administration options for patients while continuing to build its neuromuscular disease portfolio.
• Roche has outperformed both the Swiss market and pharmaceutical industry with a 33.01% total shareholder return over the past year, bolstered by strategic collaborations and regulatory approvals.
DARZALEX® Subcutaneous Regimen Receives CHMP Backing for Newly Diagnosed Multiple Myeloma Treatment
• Johnson & Johnson's DARZALEX® subcutaneous formulation combined with VRd receives positive CHMP recommendation for treating newly diagnosed multiple myeloma patients, regardless of transplant eligibility.
• The recommendation is supported by the Phase 3 CEPHEUS study, which evaluated the efficacy of daratumumab-VRd compared to VRd alone in 395 patients with newly diagnosed multiple myeloma.
• DARZALEX® has demonstrated significant impact in multiple myeloma treatment, having been used in over 618,000 patients worldwide and currently approved in eight indications.
FDA Grants Priority Review to Troriluzole for Spinocerebellar Ataxia Treatment
• Biohaven's troriluzole has received FDA Priority Review for treating spinocerebellar ataxia (SCA), potentially becoming the first FDA-approved treatment for this rare genetic neurodegenerative disease.
• Clinical trials demonstrated troriluzole slowed SCA disease progression by 50-70% over three years, representing a 1.5-2.2 year delay in disease advancement compared to controls.
• The FDA's decision on the New Drug Application is expected in Q3 2025, with Biohaven prepared to commercialize troriluzole in the US by 2025 if approved.
Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones
• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M).
• The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma.
• Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.
Eculizumab Shows Promise in Treating Thymoma-Associated Myasthenia Gravis
• A real-world study demonstrates that eculizumab significantly reduces Myasthenia Gravis Activities of Daily Living (MG-ADL) scores in patients with thymoma-associated myasthenia gravis.
• The research indicates a substantial decrease in the need for corticosteroids among patients treated with eculizumab by week 12.
• Clinically meaningful improvements were observed in 81.8% of patients, with initial benefits appearing within an average of 1.7 weeks after starting eculizumab.
• The study suggests eculizumab is a safe and effective treatment option for this severe myasthenia gravis subtype, warranting further investigation through larger randomized controlled trials.
Nipocalimab Receives FDA Priority Review for Generalized Myasthenia Gravis Treatment
• The FDA granted Priority Review to nipocalimab for treating gMG in antibody-positive patients, expediting its potential availability to patients.
• Phase 3 Vivacity-MG3 study results supported the application, demonstrating sustained disease control and significant MG-ADL score reduction.
• Nipocalimab, a monoclonal antibody, aims to reduce IgG autoantibodies, addressing the underlying cause of gMG without broad immunosuppression.
• Johnson & Johnson also submitted a Marketing Authorisation Application to the EMA, seeking approval of nipocalimab in gMG in Europe.
VYVDURA Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
• Japan's MHLW has approved VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) for treating adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
• VYVDURA is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP treatment, administered as a weekly subcutaneous injection.
• The approval is based on the ADHERE study, which demonstrated a 61% reduction in relapse risk compared to placebo (p<0.0001) and clinical improvement in 69% of patients.
• This approval expands treatment options for CIDP patients in Japan, offering a convenient at-home self-injection alternative.
EMA Accepts GSK's Depemokimab for Review in Asthma and CRSwNP
• The European Medicines Agency (EMA) has accepted GSK's application for depemokimab as an add-on treatment for asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
• Depemokimab, a monoclonal antibody targeting IL-5, could become the first ultra-long-acting biologic with a six-month dosing schedule if approved.
• Regulatory submissions are supported by positive results from the SWIFT and ANCHOR trials, demonstrating reduced exacerbations and polyp size, respectively.
• Asthma affects over 42 million people in Europe, while CRSwNP impacts up to 4% of the general population, highlighting the need for new treatment options.
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Daratumumab Plus VRd Improves Outcomes in Transplant-Ineligible Multiple Myeloma Patients
• The phase 3 CEPHEUS trial demonstrated that adding daratumumab to VRd significantly improved outcomes for transplant-ineligible newly diagnosed multiple myeloma patients.
• The quadruplet regimen achieved a 60.9% minimal residual disease (MRD) negativity rate compared to 39.4% with VRd alone, demonstrating a significant increase in treatment depth.
• Progression-free survival was also significantly improved with the daratumumab regimen, showing a 43% reduction in the risk of disease progression or death.
• These results suggest that daratumumab plus VRd could become a new standard of care for transplant-ineligible multiple myeloma patients, offering improved disease control.
EMA Committee Backs Roche's Phesgo, A Novel Subcutaneous Combination of Herceptin and Perjeta for HER2+ Breast Cancer
• The EMA's human medicines committee (CHMP) has recommended approval of Phesgo, a fixed-dose combination of trastuzumab and pertuzumab for HER2-positive breast cancer treatment.
• The subcutaneous formulation significantly reduces administration time from over two hours to just five minutes after initial loading dose, offering greater convenience and reduced clinic visits during the pandemic.
• Phesgo's approval would strengthen Roche's portfolio as it faces biosimilar competition for Herceptin, with the combination product already approved and available in the US market.
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