Lugano, Switzerland, December 2, 2021 – Helsinn Group, a fully integrated, global biopharma
company with a diversified pipeline of innovative oncology assets and strong track-record of
commercial execution, is pleased to announce that the European Commission (EC) has approved
the liquid formulation of AKYNZEO® (fosnetupitant/palonosetron).
AKYNZEO® 235 mg/0.25 mg concentrate for solution for infusion is indicated for the prevention
of acute and delayed nausea and vomiting associated with both highly emetogenic cisplatinbased cancer chemotherapy and moderately emetogenic cancer chemotherapy.
The ready-to-dilute formulation provides several improvements to storage and handling in
comparison to previously approved formulations:
• AKYNZEO®235 mg/0.25 mg concentrate for solution for infusion does not require
refrigeration at any stage of distribution, preparation or storage.
• AKYNZEO® 235 mg/0.25 mg concentrate for solution for infusion eliminates the need for
reconstitution prior to dilution, reducing the preparation process for intravenous
administration of AKYNZEO®
to one step before use.
• AKYNZEO® 235 mg/0.25 mg concentrate for solution for infusion may now be stored for
up to 24 hours at room temperature after dilution, allowing more flexibility in preparation
for busy clinicians.
Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “The EU approval is
an important milestone for this improved formulation of AKYNZEO®. The ready-to-dilute
formulation allows easier preparation and administration of the drug, providing caregivers with an
additional tool that we believe is important as they seek to reduce the debilitating side effect of
chemotherapy-induced nausea and vomiting (CINV) in chemotherapy patients.” ”
AKYNZEO® (netupitant 300mg/palonosetron 0.5mg) capsules for oral use was approved in May
2015 in the EU. A line extension to introduce the IV formulation AKYNZEO® (fosnetupitant
235mg/palonosetron 0.25mg) powder for concentrate for solution for infusion was approved in
March 2020 in the EU. A line extension to introduce the IV formulation AKYNZEO®
(fosnetupitant 235mg/palonosetron 0.25mg) concentrate for solution for infusion has being
approved in EU on the 12th November 2021. Fosnetupitant is a netupitant prodrug, which
converts into netupitant once administered intravenously. AKYNZEO®
(oral and IV) is indicated
in the EU for adults for the prevention of acute and delayed nausea and vomiting associated
with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic
For additional information please see the EU Summary of Product Characteristics.
Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It
is focused on improving the lives of cancer patients all over the world with a leading position in
cancer supportive care and innovative pipeline of cancer therapeutics.
Helsinn is a third-generation family-owned company, that since 1976 has been focused on
improving the lives of patients, guided by core values of respect, integrity and quality. It operates
a unique licensing business model with integrated drug development and manufacturing
capabilities. Helsinn has a commercial presence in over 190 countries either directly, with
operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners.
Helsinn plays an active and central role in promoting social transformation in favor of people and
the environment. Corporate social responsibility is at the heart of everything we do, which is
reinforced in the company’s strategic plan by a commitment to sustainable growth.
Group Head of Communication
Tel: +41 (0) 91 985 21 21
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