Helsinn, the Swiss Group focused on building quality cancer care, announced that the European Medicines Agency (EMA) has adopted a positive opinion recommending that the Helsinn owned Akynzeo (netupitant-palonosetron), a new oral fixed dose combination of a highly-selective NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, be granted approval for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.
The Committee for Medicinal Products for Human Use (CHMP) is the committee of the European Medicines Agency responsible for preparing opinions on questions concerning medicines for human use.
This is the first opinion given by the CHMP for a fixed dose combination targeting two key pathways involved in chemotherapy-induced nausea and vomiting (CINV) and will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union (EU).
Akynzeo was approved on October 10th 2014 by the US Food and Drug Administration (FDA), 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.
“After the approval of Akynzeo by the FDA, we are proud to achieve this latest milestone with Akynzeo providing patients going through cancer treatment across Europe with an additional option for CINV protection,” said Riccardo Braglia, Helsinn Group chief executive officer. “We anticipate that, when approved, Akynzeo will play a significant role in preventing nausea and vomiting in both the acute and delayed phases, following moderately or highly emetogenic chemotherapy regimens. Simplification of therapy by decreasing the number of individual dose units may furthermore improve patient compliance and guidelines adherence.”
The positive CHMP opinion was based on data from phase 2 and phase 3 studies with Akynzeo including more than 2500 patients undergoing treatment with moderately and highly emetogenic chemotherapy regimens for a variety of tumor types. The adverse events reported with Akynzeo were consistent with the safety profile of the NK1 and 5-HT3 receptor antagonist classes of drugs.
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 USA 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.