Hyaluronidase
- Generic Name
- Hyaluronidase
- Brand Names
- Amphadase
- Drug Type
- Biotech
- CAS Number
- 9001-54-1
- Unique Ingredient Identifier
- 8KOG53Z5EM
- Background
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 Therapies
- Parenteral rehydration therapy, Parenteral drug administration, Subcutaneous urography
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.
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.
AstraZeneca Partners with Alteogen to Develop Subcutaneous Oncology Treatments Using Novel Hyaluronidase Technology
• AstraZeneca has secured worldwide rights to Alteogen's ALT-B4 hyaluronidase technology to develop subcutaneous formulations of several oncology drugs currently administered intravenously.
• The exclusive license agreement includes an upfront payment to Alteogen, milestone-based payments, and royalties on commercialized products, with Alteogen maintaining responsibility for clinical and commercial supply of ALT-B4.
• Alteogen's Hybrozyme technology enables large-volume subcutaneous administration by temporarily breaking down hyaluronan in the extracellular matrix, potentially transforming cancer care delivery with more convenient treatment options.
AstraZeneca Acquires EsoBiotec for Up to $1 Billion to Transform Cancer Cell Therapy
• AstraZeneca has agreed to acquire Belgium-based EsoBiotec for up to $1 billion, with an initial payment of $425 million and additional milestone-based payments of up to $575 million.
• EsoBiotec's Engineered NanoBody Lentiviral (ENaBL) platform enables in vivo modification of immune cells, potentially reducing cell therapy delivery time from weeks to minutes through a simple injection.
• The acquisition, expected to close in Q2 2025, aims to revolutionize cancer treatment by making cell therapies more accessible and efficient for patients while expanding AstraZeneca's oncology portfolio.
AstraZeneca's Eneboparatide Meets Primary Endpoint in Phase III Trial for Hypoparathyroidism
• Eneboparatide, an investigational parathyroid hormone receptor agonist, successfully normalized serum calcium levels and eliminated the need for standard supplementation in adults with chronic hypoparathyroidism at 24 weeks.
• The CALYPSO Phase III trial enrolled 202 patients and will continue to 52 weeks to further characterize the drug's long-term safety and efficacy profile, with full data to be shared with global health authorities.
• Hypoparathyroidism affects over 200,000 people in the US and EU, with approximately 80% being women, representing a significant unmet medical need despite existing treatments.
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.
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.
Takeda's HYQVIA Approved in Japan for Agammaglobulinemia and Hypogammaglobulinemia
• Japan's MHLW has approved Takeda's HYQVIA for treating agammaglobulinemia and hypogammaglobulinemia, conditions marked by low antibody levels.
• HYQVIA is the first facilitated subcutaneous immunoglobulin therapy available in Japan, offering less frequent dosing.
• The approval is based on Phase III trials in Japanese and North American patients, demonstrating efficacy and manageable side effects.
• HYQVIA provides a reduced dosing frequency of every three to four weeks, compared to weekly or bi-weekly dosing schedules.
Teclistamab Shows Promise as Frontline Therapy for Multiple Myeloma in Newly Diagnosed Patients
• Teclistamab-based regimens demonstrated high rates of MRD negativity in newly diagnosed multiple myeloma patients in the MajesTEC-5 study.
• The MajesTEC-4 study highlighted teclistamab's potential as maintenance therapy post-autologous stem cell transplant, showing low TEAEs.
• Both studies presented at ASH 2024 indicate a manageable safety profile for teclistamab in frontline settings, supporting its combinability.
• Ongoing MajesTEC-7 trial will further evaluate teclistamab in combination with daratumumab and lenalidomide for NDMM patients.
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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.
CHMP Recommends Rybrevant Plus Lazcluze for EGFR-Mutated NSCLC in the EU
• The CHMP has recommended Rybrevant in combination with Lazcluze for first-line treatment of EGFR-mutated advanced non-small cell lung cancer (NSCLC).
• The recommendation is supported by Phase III MARIPOSA study data, which showed a 30% reduction in the risk of disease progression or death compared to Tagrisso.
• A subcutaneous formulation of Rybrevant, developed with Halozyme's ENHANZE technology, also received a positive CHMP opinion for NSCLC treatment.
• The CHMP also recommended a Type II indication extension for amivantamab in the same combination treatment.
CHMP Recommends Subcutaneous Amivantamab for EGFR-Mutated NSCLC Treatment
• The CHMP has recommended subcutaneous amivantamab with lazertinib for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• Subcutaneous amivantamab monotherapy is recommended for NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
• PALOMA-3 study results support the recommendation, showing non-inferior pharmacokinetics and a five-fold reduction in infusion-related reactions compared to IV administration.
• The subcutaneous formulation reduces administration time to approximately five minutes, offering improved convenience and safety for patients.
Johnson & Johnson Seeks Approval for Darzalex Faspro in High-Risk Smoldering Multiple Myeloma
• Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
• The applications are based on Phase 3 AQUILA study data, evaluating Darzalex Faspro monotherapy versus active monitoring.
• Smoldering multiple myeloma is an early-stage precursor to active multiple myeloma, often asymptomatic until progression.
• Darzalex Faspro could potentially become the first approved treatment for high-risk smoldering multiple myeloma, shifting the treatment paradigm.
J&J Seeks FDA and EMA Approval for Darzalex Faspro in High-Risk Smoldering Multiple Myeloma
• Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
• The applications are based on data from the Phase 3 AQUILA study, which evaluated Darzalex Faspro as a monotherapy.
• Smoldering multiple myeloma is an early precursor to active multiple myeloma, often monitored until progression.
• Darzalex Faspro could become the first approved treatment for high-risk smoldering multiple myeloma, potentially changing the treatment paradigm.
Johnson & Johnson Seeks Approval for Darzalex Faspro in High-Risk Smoldering Multiple Myeloma
• Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
• The applications are based on Phase 3 AQUILA study data, evaluating Darzalex Faspro monotherapy versus active monitoring.
• Smoldering multiple myeloma is an early-stage precursor to active myeloma, with a high risk of progression in some patients.
• Darzalex Faspro could potentially become the first approved treatment for high-risk smoldering multiple myeloma, shifting the treatment paradigm.
Johnson & Johnson Seeks Approval for Darzalex FASPRO® in High-Risk Smoldering Multiple Myeloma
• Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex FASPRO® to treat high-risk smoldering multiple myeloma.
• The applications are based on Phase 3 AQUILA study data, evaluating Darzalex FASPRO® monotherapy versus active monitoring.
• If approved, Darzalex FASPRO® could become the first treatment for high-risk smoldering multiple myeloma, intervening before active disease.
• The AQUILA study results will be presented at the American Society of Hematology (ASH) Annual Meeting in December.
Daratumumab Seeks Approval for High-Risk Smoldering Multiple Myeloma
• Johnson & Johnson has submitted applications to the FDA and EMA for subcutaneous daratumumab to treat high-risk smoldering multiple myeloma.
• The applications are supported by data from the phase 3 AQUILA study, with initial findings expected at the upcoming ASH meeting.
• Daratumumab targets CD38 and, if approved, could become the first treatment for this early stage of multiple myeloma.
• The AQUILA trial assesses daratumumab vs. active surveillance, with progression-free survival as the primary endpoint.
Johnson & Johnson Seeks Approval for Darzalex Faspro in Smoldering Multiple Myeloma
• Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
• The applications are based on the Phase 3 AQUILA study, which evaluated Darzalex Faspro versus active monitoring in patients with the condition.
• Smoldering multiple myeloma is an asymptomatic precursor to multiple myeloma, with a high risk of progressing to active disease within two years for some patients.
• Multiple myeloma is the second most common blood cancer, and Darzalex Faspro could offer a new treatment option for patients with the precursor condition.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
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