Aloxi gains approval in Europe

Three months after the CHMP's recommendation to approve anti-nausea drug Aloxi, the European Commission has granted marketing authorisation to Swiss pharmaceutical group Helsinn Healthcare.

Aloxi prevents the acute nausea and vomiting associated with both high and moderate emetogenic cancer chemotherapy.

Belonging to the second generation of serotonin subtype 3 (5-HT3) receptor antagonists, several clinical trials showed a greater efficacy of Aloxi during the acute and delayed phases after chemotherapy treatment. The high receptor binding affinity was at least 30 times higher than the first generation 5-HT3 receptor antagonists.

Chemotherapy induced nausea and vomiting (CINV) is estimated to affect 85% of cancer patients who undergo chemotherapy and can result in a delay or discontinuation of chemotherapy treatments. With an extended plasma half-life of approximately 40 hours, Aloxi improves patients' chances of completing their treatment course successfully and increases their quality of life.

The National Comprehensive Cancer Network, an alliance of 19 of the world's leading cancer centers, recently indicated Aloxi as the treatment of choice for the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy.

'This news is of great significance for Helsinn,' said Dr. Enrico Braglia, md at Helsinn. ' We have completed the centralised procedure registration in Europe for the first time, and will ensure that Aloxi is made available throughout the EU country as soon as possible through our local partners and distributors.'

Helsinn has also announced a number of licensing and distribution agreements across Europe; including Cambridge Laboratories in the UK, Ribosepharm in Germany, Italfarmaco in Italy and Spain, Galenica in Greece, CSC in Austria, and PharmaSwiss for Slovenia and the Baltic States.