FDA Approves Akynzeo for Injection
`FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for
`Chemotherapy-Induced Nausea and Vomiting
`Lugano, Switzerland April 20, 2018 – Helsinn, a Swiss pharmaceutical group focused on building quality
`cancer care products, today announces that the U.S. Food and Drug Administration (FDA) has approved
`the intravenous formulation of Akynzeo (NEPA, a fixed antiemetic combination of fosnetupitant, 235mg,
`and palonosetron, 0.25mg) as an alternative treatment option for patients experiencing CINV.
`The FDA has approved Akynzeo IV in combination with dexamethasone in adults for the prevention of
`acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic
`cancer chemotherapy. Akynzeo for injection has not been studied for the prevention of nausea and
`vomiting associated with anthracycline plus cyclophosphamide chemotherapy.
`Oral Akynzeo was previously approved by the FDA as a fixed combination oral agent in 2014 for the
`prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of
`cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Akynzeo is an oral
`fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the
`acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase
`after cancer chemotherapy.
`The bioequivalence of the IV with the oral formulation of netupitant was demonstrated and the safety of
`IV NEPA was established through a repeated dose safety study in cancer patients to potentially uncover
`adverse drug reactions that may appear during subsequent clinical practice. No anaphylactic and
`injection site reactions related to IV NEPA were reported in this study.
`Currently a repeated dose safety study is ongoing in patients receiving anthracycline plus
`cyclophosphamide to further establish the safety profile in this setting.
`The prevention of CINV has been refined in treatment guidelines over the past several decades.
`Currently the combination treatment of antiemetic medicines with different mechanisms of actions are
`recommended for the prevention of CINV.
`The approval of Akynzeo in IV formulation will offer to US patients and healthcare providers an
`alternative route of administration of the only fixed antiemetic combination targeting two distinct CINV
`pathways in a single dose.
`8/3/25, 3:31 PM FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting
`https://www.drugs.com/newdrugs/fda-approves-intravenous-formulation-akynzeo-fosnetupitant-palonosetron-chemotherapy-induced-nausea-4726.html 1/3
`HELSINN EXHIBIT 2020
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00945
`Page 1 of 3
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`Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “The approval of the intravenous
`formulation of Akynzeo paves the way to bring this important therapeutic option to more patients in a
`new formulation, and we are delighted that we are now able to push ahead with launching this product in
`the United States in May 2018”
`Helsinn plans to launch Akynzeo in IV formulation in the US in May 2018.
`About Akynzeo
`INDICATION
`Akynzeo (netupitant 300mg/palonosetron 0.5mg) capsules was approved in October 2014 in the United
`States and is indicated in combination with dexamethasone in adults for the prevention of acute and
`delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy,
`including, but not limited to, highly emetogenic chemotherapy.
`Akynzeo (fosnetupitant 235mg/palonosetron 0.25) for injection was approved in April 2018 in the United
`States and is indicated in combination with dexamethasone in adults for the prevention of acute and
`delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer
`chemotherapy.
`Limitations of Use
`Akynzeo for injection has not been studied for the prevention of nausea and vomiting associated with
`anthracycline plus cyclophosphamide chemotherapy.
`Akynzeo is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or
`fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and
`vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both
`the acute and delayed phase after cancer chemotherapy.
`About the Helsinn Group
`Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care
`products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday
`lives of patients, guided by core family values of respect, integrity and quality. The Group works across
`pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in
`research, development, manufacture and the commercialization of therapeutic and supportive care
`products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn
`Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The
`8/3/25, 3:31 PM FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting
`https://www.drugs.com/newdrugs/fda-approves-intravenous-formulation-akynzeo-fosnetupitant-palonosetron-chemotherapy-induced-nausea-4726.html 2/3
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`company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland,
`the U.S., Monaco and China, as well as a product presence in approximately 190 countries globally.
`Source: Helsinn
`Posted: April 2018
`Akynzeo for Injection (fosnetupitant and palonosetron) FDA Approval History
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`8/3/25, 3:31 PM FDA Approves Intravenous Formulation of Akynzeo (fosnetupitant/palonosetron) for Chemotherapy-Induced Nausea and Vomiting
`https://www.drugs.com/newdrugs/fda-approves-intravenous-formulation-akynzeo-fosnetupitant-palonosetron-chemotherapy-induced-nausea-4726.html 3/3
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