WOODCLIFF LAKE, N.J., Jan. 18, 2017 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today that it is participating in Access Accelerated, a global partnership to advance access to non-communicable diseases (NCDs) prevention, treatment and care in low and lower-middle income countries.
Access Accelerated is the first multi-stakeholder, international initiative in the field of NCDs, consisting of 22 major pharmaceutical companies, including Eisai, in collaboration with the World Bank Group and the Union for International Cancer Control (UICC). The aim of Access Accelerated is to work towards the United Nation's Sustainable Development Goal target of reducing the number of premature deaths from NCDs in low and lower-middle income countries by one-third by 2030. In addition to the individual programs to improve access to health care run by each of the participating companies, this initiative will conduct pilots for improving prevention, treatment and care of NCDs in collaboration with the World Bank Group. Furthermore, in collaboration with the UICC, this initiative will support the provision of effective, sustainable diagnosis and treatment, for the purpose of improving cancer treatment and care.
To address global NCDs issues, Eisai has been running various initiatives in each country to improve access, including an Alzheimer's disease awareness and early detection campaign in China, and the introduction of tiered pricing, an affordable pricing model for our global metastatic breast cancer agent HALAVEN® in seven Asian countries, including India, Thailand and the Philippines, where prices are set at several levels in accordance with the income levels of patients.
With regard to Eisai's participation in Access Accelerated, CEO Haruo Naito commented: "One of the missions of the modern pharmaceutical industry is to make drugs accessible to all patients, no matter their socioeconomic status. In line with its human health care (hhc) philosophy, Eisai is pleased to take part in initiatives like Access Accelerated to help address the social and medical needs of patients and their caregivers. For Eisai, pursuing solutions for global access challenges is both our responsibility and a long-term investment into the future."
To learn more about Eisai's involvement in the Access Accelerated initiative, please visit www.eisai.com/company/atm/accessaccelerated.html.
About HALAVEN® (eribulin mesylate) Injection
HALAVEN® (eribulin mesylate) is a microtubule dynamics inhibitor indicated for the treatment of patients with:
- Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
- Unresectable or metastatic liposarcoma who have received a prior anthracycline- containing regimen.
Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, Halaven is a microtubule dynamics inhibitor. Eribulin is believed to work via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.
Important Safety Information for Halaven (eribulin mesylate) Injection
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.
Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving Halaven and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold Halaven in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
Embryo-Fetal Toxicity: Halaven can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Halaven and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Halaven and for 3.5 months following the final dose.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating Halaven and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
In patients with mBC receiving Halaven (eribulin mesylate) Injection, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).
In patients with liposarcoma and leiomyosarcoma receiving Halaven, the most common adverse reactions (≥25%) reported in patients receiving Halaven were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving Halaven were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).
Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with Halaven and for 2 weeks after the final dose.
Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.
For more information about Halaven, click here for the full Prescribing Information.
About Access Accelerated
Access Accelerated is a first-of-its-kind, multi-stakeholder collaboration focused on improving NCDs care. Involving more than 20 biopharmaceutical companies, the initiative works with partners such as World Bank Group and the Union for International Cancer Control (UICC) to help overcome a variety of access barriers to NCDs medicines in low-income and lower-middle income countries. Access Accelerated will support multi-stakeholder dialogue and begin on-the-ground work to improve NCDs prevention, diagnosis and treatment.
Contributing companies include: Almirall, Astellas, Bayer, Bristol-Myers Squibb, Celgene, Chugai, Daiichi Sankyo, Eisai, Eli Lilly and Company, EFPIA, GlaxoSmithKline, The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Johnson & Johnson, JPMA, Menarini, Merck, MSD, Novartis, Pfizer, PhRMA, Roche, Sanofi, Shionogi, Sumitomo Dainippon, Takeda and UCB. IFPMA will act as the Secretariat for Access Accelerated. For more information, please visit accessaccelerated.org.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Co. Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including oncology and neurology. For more information about Eisai Co., Ltd., please visit www.eisai.com.
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