The US Food and Drug Administration has approved Helsinn and Eisai’s Akynzeo to treat chemotherapy-induced nausea and vomiting.

Akynzeo is a combination of oral palonosetron, already marketed by Eisai (and developed by Helsinn) to prevent vomiting and nausea within the first 24 hours of chemotherapy, and netupitant, a new drug which prevents the two during both the acute and delayed phase (from 25 to 120 hours) after the start of chemotherapy.

The combo’s effectiveness was established in two trials of 1,720 participants. In the first, 98.5%, 90.4% and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. That compared to 89.7%, 80.1% and 76.5% treated with oral palonosetron, said the FDA, noting that the second trial showed similar results.

Common side effects seen in the trials of Akynzeo, licensed by Eisai from Helsinn, were headache, weakness (asthenia), fatigue, indigestion and constipation.