FDA Approves ALOXI® (palonosetron HCl) to Prevent Nausea and Vomiting due to Chemotherapy in Children as Young as 1 Month

WOODCLIFF LAKE, N.J. and LUGANO, Switzerland, May 28, 2014 /PRNewswire/ -- Eisai Inc. and Helsinn Group today announced the Food and Drug Administration (FDA) approval of ALOXI^® (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 month to less than 17 years.  This is the first approval of a product for acute chemotherapy-induced nausea and vomiting (CINV) prevention in patients aged 1 month to 6 months.  The age of peak cancer incidence among children occurs within the first year of life, so this approval offers an important option to children, and especially infants, undergoing chemotherapy.

CINV is among the most common side effects following therapy in patients with cancer.  In clinical trials, CINV has been seen in 35 - 80 percent of pediatric patients.

"We are pleased with the Agency's decision to approve ALOXI in the pediatric setting, giving children with cancer another option to help prevent acute chemotherapy-induced nausea and vomiting," said Yuji Matsue, Chairman and CEO, Eisai Inc.  "Cancer treatment is trying as it is.  Our hope is that an additional option may help make cancer treatment less nauseating for some patients."

"The prevention of nausea and vomiting induced by chemotherapy remains an unmet need in children, despite available therapies," said Riccardo Braglia, CEO, Helsinn Group.  "This approval provides access to a new treatment option for CINV prevention."

In response to a written request from the FDA, Helsinn conducted four pediatric clinical trials with ALOXI.  The approval was based on a randomized, double-blind, non-inferiority pivotal trial comparing single-dose intravenous (IV) ALOXI 20 mcg/kg given 30 minutes prior to chemotherapy to a standard of care IV ondansetron regimen of 0.15 mg/kg given 30 minutes prior to chemotherapy followed by infusions four and eight hours after the first dose of ondansetron.  Within the first 24 hours after chemotherapy, Complete Response, defined as no vomiting, no retching and no antiemesis rescue medication, was achieved in 59.4 percent of patients who received ALOXI 20 mcg/kg versus 58.6 percent of those who received the ondansetron regimen.  This demonstrated that single-dose ALOXI met its primary endpoint.

Treatment-emergent adverse events (TEAEs) were comparable across both arms, with the most frequently reported TEAE in the palonosetron group being headaches.  While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent CINV, the safety profile is consistent with the established profile in adults.

About Chemotherapy-Induced Nausea and Vomiting
Chemotherapy-induced nausea and vomiting is among the most common side effects following therapy in patients with cancer.  In clinical trials, CINV has been seen in 35 - 80 percent of pediatric patients.  5-HT₃ receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema.  It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT₃ receptors located on vagal afferents to initiate the vomiting reflex.

About ALOXI^® (palonosetron HCl)
Indication in Adults
ALOXI injection is used in adults to help prevent nausea and vomiting when it happens right away or later (up to five days) with certain anti-cancer medicines (chemotherapy).

Indication in Pediatrics
ALOXI is used in children 1 month old to less than 17 years of age to help prevent nausea and vomiting that happens right away (up to 24 hours) with certain anti-cancer medicines (chemotherapy).

Important Safety Information

• ALOXI can cause allergic reactions that can be serious.  Tell your doctor or nurse right away if you have any of these following symptoms of a serious allergic reaction: hives, swelling of the face, trouble breathing and chest pain
• The most common side effects of ALOXI in adults are headache and constipation
• Tell your doctor or nurse if you are taking other medications or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed

ALOXI is available by prescription only.

For more information about ALOXI, click here for the full Product Information or visit www.ALOXI.com.

About Helsinn and Eisai Inc.
Eisai Inc. gained the exclusive marketing rights to ALOXI in the U.S. and Canada from Helsinn Healthcare S.A. through its acquisition of MGI PHARMA, Inc. in 2008.  In 2010, Helsinn signed a Detail Services Agreement with Eisai Inc. to co-promote ALOXI in the U.S. market.  Under the terms of the agreement, Helsinn established a new oncology sales organization in 2013 that began co-detailing ALOXI in the United States, along with the Eisai sales force. 

About Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products.  Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a Representative Office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities.  Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.

About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, 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 help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US. 

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

SOURCE Eisai Inc.