CONSHOHOCKEN WEST, PA., September 28, 2021 / PRNewswire / – BTG Specialty Pharmaceuticals announced that Ohara Pharmaceutical Co., Ltd. has obtained the marketing authorization for glucarpidase from from Japan Ministry of Health, Labor and Welfare as a therapeutic agent for “detoxification in the event of delayed elimination of methotrexate with rescue treatment with methotrexate-leucovorin”, on September 28, 2021. Ohara will sell glucarpidase in Japan with the brand name MegludaseÂ®.
The Japanese Ministry of Health, Labor and Welfare granted this authorization based on the efficacy and safety results of clinical studies conducted in Japan and overseas, including a researcher-initiated study known as CPG2-PII funded by the Japan Medical Association. Ohara was responsible for the glucarpidase development program and registration in Japan under a 2011 license agreement with BTG.
Christon Hill, vice president of product lifecycle management, said: âThere is an urgent need for a reliable rescue therapy for toxic methotrexate concentration in patients whose clearance is delayed due to insufficient renal. , we are increasingly excited about the potential of Voraxaze to improve cancer patient care around the world. ”
In August 2020, BTG filed for marketing authorization for VoraxazeÂ® (glucarpidase) with the European Medicines Agency (EMA) for the treatment of adults and children (from 28 days of age) at risk of methotrexate toxicity due to delayed elimination of methotrexate. The EMA examines the application under the centralized marketing authorization procedure. If Voraxaze approvedÂ® would receive a marketing authorization in all Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.
Marketed by BTG under the name VoraxazeÂ® in the United States, the United States Food and Drug Administration granted marketing authorization for glucarpidase in 2012. In the United States, VoraxazeÂ® is a carboxypeptidase indicated to reduce the plasma concentration of toxic methotrexate (greater than 1 micromole per liter) in adult and pediatric patients with delayed clearance of methotrexate (plasma concentrations of methotrexate greater than 2 standard deviations of the excretion curve methotrexate specific to the dose of methotrexate administered) due to renal impairment.
VoraxazeÂ® is also the subject of independent studies in Europe and the United States to determine whether routine administration of VoraxazeÂ® in combination with high dose methotrexate may lessen toxicity, manage risk to patients and help them complete treatment. Registration for these studies is in progress. For more information on these studies or to contact a researcher about participation, please visit ClinicalTrials.gov.
About Ohara Pharmaceutical Co., Ltd.
Ohara Pharmaceutical Co., Ltd. is a pharmaceutical company that discovers and develops orphan and generic drugs as its core business. The company is particularly focused on the development, manufacture and marketing of orphan drugs for pediatric cancer and other fields, as well as on the development, manufacture and marketing of generic drugs which are involved in the prevention of medical accidents. Ohara Pharmaceutical aims to become a company that provides a complete healthcare solution by promoting innovations not only in treatment, but also in prevention, diagnosis and monitoring that affect the quality of healthcare in a healthcare environment. evolving health outcomes and improve treatment outcomes.
About BTG Specialty Pharmaceuticals.
BTG Specialty Pharmaceuticals provides antidotes that counteract the life-threatening effects associated with exposure or overexposure to certain toxins. These acute care products are typically used in emergency rooms and intensive care units to treat patients for whom treatment options are limited or nonexistent. We are committed to providing quality medicines that make a real difference to patients through the development, manufacture and commercialization of pharmaceuticals. To learn more about BTG Pharmaceuticals, please visit: btgsp.com.
VORAXAZEÂ® INDICATION AND LIMITS OF USE
- VoraxazeÂ® is a carboxypeptidase indicated to reduce the plasma concentration of toxic methotrexate (greater than 1 micromole per liter) in adult and pediatric patients with delayed clearance of methotrexate (plasma concentrations of methotrexate greater than 2 standard deviations of the excretion curve mean methotrexate specific to the dose of methotrexate administered) due to renal impairment
- Limits of use: VoraxazeÂ® is not recommended in patients with the expected clearance and plasma concentration of methotrexate. Decreased plasma concentration of methotrexate in these patients may result in sub-therapeutic exposure to methotrexate.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions
- Serious hypersensitivity reactions, including anaphylactic reactions, can occur. Serious hypersensitivity reactions have occurred in less than 1% of patients
Monitoring Methotrexate Concentration / Test Interference
- Methotrexate levels within 48 hours of VoraxazeÂ® administration can only be reliably measured by a chromatographic method due to interference from metabolites. Measurement of methotrexate concentrations within 48 hours of VoraxazeÂ® administration with immunoassays results in an overestimation of the concentration of methotrexate
- In clinical trials, the most common associated adverse events (occurring in> 1% of patients) were paresthesia, flushing, nausea and / or vomiting, hypotension, and headache.
- VoraxazeÂ® may decrease the concentration of leucovorin, which may decrease the effect of leucovorin rescue unless leucovorin is administered as recommended, and may also reduce the concentrations of other folate analogues or metabolic inhibitors of folate analogues
Please see full prescribing information.
1.Widemann BC, Balis FM, Kim A, et al. Glucarpidase, Leucovorin, and Thymidine for High Dose Methotrexate-Induced Renal Dysfunction: Clinical and Pharmacological Factors Affecting Outcome. J Clin Oncol. 2010; 28 (25): 3979-3986.
2.2013 Annual Meeting of the North American Congress of Clinical Toxicology (NACCT). Clin Toxicol. 2013; 51 (7): 575-724.
3.VoraxazeÂ® [prescribing information]. BTG International Inc .; 2019.
4.Howard SC, McCormick J, Pui CH, et al. Prevent and manage the toxicities of high dose methotrexate. Oncologist. 2016; 21 (12): 1471-1482.
5.Demiralp B, Koenig L, Kala J, et al. Length of stay, mortality, and readmissions in Medicare cancer patients treated with glucarpidase and conventional care: a retrospective study. Results Clinicoecon Res. 2019; 11: 129-144.
SOURCE BTG Specialties Pharmaceuticals