Helsinn Group announced on April 2, 2025, the submission of a new formulation of AKYNZEO® to the European Medicines Agency (EMA) for regulatory review. The drug is currently indicated for the prevention of both acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.
The Switzerland-based pharmaceutical company expects to launch this innovative formulation in the first half of 2026, pending regulatory approval. While specific details about the new formulation have not been disclosed, the company indicates it may provide additional benefits to cancer patients beyond those offered by currently approved versions of the medication.
Roberta Cannella, Chief Technical Officer at Helsinn, emphasized the significance of this development: "This submission brings us closer to offering patients a new option for AKYNZEO®. It not only demonstrates our commitment to enhancing patients' quality of life but also our dedication to innovation in supportive care."
Understanding AKYNZEO® and Its Clinical Significance
AKYNZEO® holds a unique position in the management of chemotherapy-induced nausea and vomiting (CINV), a common and distressing side effect that can significantly impact cancer patients' quality of life and treatment adherence. The drug represents the first and only fixed-dose combination of 5-HT3 and NK1 receptor antagonists approved for adult patients.
This dual-action approach targets two critical pathways involved in CINV. The 5-HT3 receptor antagonist component helps control acute nausea and vomiting that occurs within 24 hours of chemotherapy administration, while the NK1 receptor antagonist addresses delayed symptoms that can persist for several days after treatment.
Chemotherapy-induced nausea and vomiting remains one of the most feared complications of cancer treatment, affecting approximately 70-80% of patients receiving highly emetogenic chemotherapy regimens without adequate prophylaxis. Effective management of these symptoms is crucial for maintaining nutritional status, preventing dehydration, and ensuring patients can complete their prescribed treatment courses.
Helsinn's Commitment to Supportive Cancer Care
This regulatory submission aligns with Helsinn's longstanding focus on supportive care in oncology. The company, headquartered in Lugano, Switzerland, has nearly fifty years of commercial experience and maintains direct operations in the United States alongside a partner network reaching patients in over 190 countries worldwide.
Established in 1976, Helsinn remains a fourth-generation family-owned enterprise with extensive pharmaceutical and technical expertise. The company has built its reputation on developing and commercializing products that improve quality of life for patients with cancer and chronic diseases.
The development of a new AKYNZEO® formulation demonstrates Helsinn's ongoing investment in its core therapeutic areas of supportive care, oncology, and dermato-oncology. By continuing to innovate within established product lines, the company aims to address evolving patient needs while building on clinically validated treatment approaches.
Looking Forward: Implications for Patient Care
While specific details about the new formulation remain limited pending the regulatory review process, improvements could potentially address aspects such as administration route, dosing convenience, or side effect profile. Any enhancements that simplify administration or improve tolerability could have meaningful impacts on patient experience during cancer treatment.
The anticipated 2026 launch timeline suggests a standard EMA review process, with potential approval coming approximately 12-14 months after submission if no major regulatory concerns arise during evaluation.
For healthcare providers managing patients undergoing chemotherapy, this development represents a potential expansion of available tools to address CINV, a condition that continues to challenge clinical management despite advances in antiemetic therapy.
As the regulatory review progresses, more information about the specific advantages of this new formulation will likely emerge, providing clearer insights into how it may complement or enhance the existing AKYNZEO® options currently available to European patients.
