News Release      
May 27, 2021 
Taiho Pharmaceutical Co., Ltd. 
Helsinn Healthcare SA 
Taiho Pharmaceutical Obtains Approval for an Additional Dosage and Administration of 5-HT3 
Receptor Antagonist Aloxi® for  
Pediatric Patients in Japan 
Taiho Pharmaceutical Co., Ltd. and HelsinnHealthcare SA, which is headquartered in 
Lugano, Switzerland, announced today that Taiho has acquired approval from the 
Japanese Ministry of Health, Labour and Welfare for an additional dosage and 
administration in pediatric patients of its 5-HT3 receptor antagonist Aloxi® I.V. injection 
0.75mg and Aloxi® I.V. infusion bag 0.75mg (generic name: Palonosetron Hydrochloride).  
Aloxi® was developed for the prevention of chemotherapy-induced nausea and vomiting, 
and, in adults, has demonstrated its efficacy in delayed nausea and vomiting where other 
conventional 5-HT3 receptor antagonists have hitherto provided insufficient effects. The 
additional indication announced today is based on the results of a Phase III clinical study 
conducted in Japan with pediatric patients aged 28 days to 18 years. The primary 
endpoint of the study was complete response (i.e., no emetic event and no rescue 
medication) from 0 to 120 hours after initiation of highly emetogenic or moderately 
emetogenic antineoplastic agents on course 1. The complete response rate was 58.6% 
(95% confidence interval: 44.9% to 71.4%), and the lower limit of the 95% confidence 
interval was above the pre-specified threshold of 30%, thus verifying the clinical benefit of 
this agent for pediatric patients. No new safety concerns have been raised respect the 
known safety profile of palonosetron agent. 
Under the license agreement signed in January 2004 with Helsinn Healthcare SA, Taiho 
Pharmaceutical acquired clinical development and marketing rights in Japan, and 
manufacturing and marketing approval was obtained for Aloxi® I.V. injection 0.75mg in 
January 2010 and for Aloxi® I.V. infusion bag 0.75mg in August 2012. Aloxi® is approved 
for the indication of prevention of chemotherapy-induced nausea and vomiting for adult 
patients in more than 80 countries and regions, and for pediatric patients in more than 60 
countries and regions.  Within Taiho’s mainstay field of oncology, the company is also focusing on cancer supportive care. It is expected that Aloxi® will contribute to preventing chemotherapy-induced nausea and vomiting in pediatric patients. 
 Product Information 
Product name Aloxi® I.V. injection 0.75mg and Aloxi® I.V. infusion bag 0.75mg 
Indication and 
usage 
Gastrointestinal symptoms (nausea and vomiting, including 
delayed phase) resulting from the administration of anticancer 
agents (cisplatin, etc.) 
Dosage and 
administration 
For intravenous and drip infusion use, the usual dosage of 
palonosetron is 0.75mg per body once daily. 
For patients aged 18 years old or younger, the usual dosage of 
palonosetron is 20 µg/kg once per day for intravenous 
administration and drip infusion and the upper dose limit is 1.5 
(Newly approved indication is underlined.) 
About Taiho Pharmaceutical Co., Ltd. (Japan) Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven 
specialty pharma company with a focus on oncology. Taiho Pharmaceutical also has 
development programs in allergy and immunology, urology and consumer healthcare 
products. Our corporate philosophy is simple: “We strive to improve human health and 
contribute to a society enriched by smiles.”  
For more information about, please visit: https://www.taiho.co.jp/en/ 
About the Helsinn Group  
Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been 
improving the lives of patients, guided by core family values of respect, integrity and 
quality. The Group has an extensive portfolio of marketed innovative cancer and rare 
disease therapies, a robust drug development pipeline and ambitions to further accelerate 
its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn 
operates a unique integrated licensing business model, achieving success with long-
standing partners in 190 countries, who share our values. 
For more information, please visit: https://helsinn.com/ 