Takeda's Regulatory Approval for HYQVIA®: A Milestone for Patients in Japan
In a significant advancement for patients suffering from rare immunodeficiency disorders, Halozyme Therapeutics has announced that Takeda Pharmaceutical Company has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) to introduce the HYQVIA® 10% subcutaneous injection set with the ENHANZE® drug delivery technology. This approval marks a crucial milestone in the treatment landscape for individuals diagnosed with agammaglobulinemia or hypogammaglobulinemia, conditions that are characterized by severely low levels of antibodies and a heightened risk of repeated infections, which are caused by either primary or secondary immunodeficiencies.
HYQVIA® is unique as it is the first plasma-derived therapeutic to be registered for subcutaneous injection in Japan. The innovative formulation combines one vial of Immune Globulin 10% (Human) and another of Recombinant Human Hyaluronidase PH20, an enzyme that enhances the absorption and dispersion of the immunoglobulin within the subcutaneous tissues. This results in the possibility of administering larger volumes without the need for intravenous access, ultimately translating to less frequent treatment sessions.
Patients can expect a remarkable decrease in the frequency of their dosing. The therapy allows for infusions every three to four weeks, as opposed to the weekly or bi-weekly schedules associated with traditional subcutaneous immunoglobulin therapies. This innovative approach not only alleviates the treatment burden but also enhances the flexibility and quality of life for those affected by these conditions.
Dr. Helen Torley, the president and CEO of Halozyme, expressed her excitement regarding the approval, stating, ‘We are extremely pleased that patients in Japan with agammaglobulinemia or hypogammaglobulinemia can now access HYQVIA, which represents the first and only subcutaneous immunoglobulin therapy that offers the potential of a reduced dosing frequency.’
The MHLW's approval was founded on the results of two Phase 3 pivotal studies, which were open-label and non-controlled, focusing on the effectiveness, safety, and pharmacokinetics of HYQVIA® in a Japanese patient population. These studies involved assessing 16 patients aged 2 years and older. Notably, the Geo Mean of the IgG trough level recorded at the last three visits was 9.494 g/L, which is comparable to levels observed with conventional treatments.
Through the ENHANZE® drug delivery system, the benefits are substantial; patients may experience reduced reliance on healthcare interventions, thus gaining greater autonomy over their treatment schedules and overall comfort during therapy. This advancement is not only a testament to Halozyme's commitment to patient-centered care but also reflects the ongoing innovations within the pharmaceutical industry to enhance treatment modalities.
Halozyme has been pioneering solutions that simplify drug delivery through its ENHANZE® technology, which has already positively impacted the lives of over 800,000 patients across an array of global markets. The company partners with notable pharmaceutical companies, including Roche, Takeda, and Pfizer, to optimize treatment delivery and improve patient outcomes.
In conclusion, the approval of HYQVIA® in Japan represents a crucial development for patients living with agammaglobulinemia and hypogammaglobulinemia. With its innovative delivery method, patients can now look forward to a healthier future with enhanced convenience and fewer disruptions to their daily lives.
HYQVIA® is unique as it is the first plasma-derived therapeutic to be registered for subcutaneous injection in Japan. The innovative formulation combines one vial of Immune Globulin 10% (Human) and another of Recombinant Human Hyaluronidase PH20, an enzyme that enhances the absorption and dispersion of the immunoglobulin within the subcutaneous tissues. This results in the possibility of administering larger volumes without the need for intravenous access, ultimately translating to less frequent treatment sessions.
Patients can expect a remarkable decrease in the frequency of their dosing. The therapy allows for infusions every three to four weeks, as opposed to the weekly or bi-weekly schedules associated with traditional subcutaneous immunoglobulin therapies. This innovative approach not only alleviates the treatment burden but also enhances the flexibility and quality of life for those affected by these conditions.
Dr. Helen Torley, the president and CEO of Halozyme, expressed her excitement regarding the approval, stating, ‘We are extremely pleased that patients in Japan with agammaglobulinemia or hypogammaglobulinemia can now access HYQVIA, which represents the first and only subcutaneous immunoglobulin therapy that offers the potential of a reduced dosing frequency.’
The MHLW's approval was founded on the results of two Phase 3 pivotal studies, which were open-label and non-controlled, focusing on the effectiveness, safety, and pharmacokinetics of HYQVIA® in a Japanese patient population. These studies involved assessing 16 patients aged 2 years and older. Notably, the Geo Mean of the IgG trough level recorded at the last three visits was 9.494 g/L, which is comparable to levels observed with conventional treatments.
Through the ENHANZE® drug delivery system, the benefits are substantial; patients may experience reduced reliance on healthcare interventions, thus gaining greater autonomy over their treatment schedules and overall comfort during therapy. This advancement is not only a testament to Halozyme's commitment to patient-centered care but also reflects the ongoing innovations within the pharmaceutical industry to enhance treatment modalities.
Halozyme has been pioneering solutions that simplify drug delivery through its ENHANZE® technology, which has already positively impacted the lives of over 800,000 patients across an array of global markets. The company partners with notable pharmaceutical companies, including Roche, Takeda, and Pfizer, to optimize treatment delivery and improve patient outcomes.
In conclusion, the approval of HYQVIA® in Japan represents a crucial development for patients living with agammaglobulinemia and hypogammaglobulinemia. With its innovative delivery method, patients can now look forward to a healthier future with enhanced convenience and fewer disruptions to their daily lives.
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