FDA Approves Another Eisai Chemotherapy Side Effects Drug

The FDA approved Eisai’s Akynzeo to treat nausea and vomiting from chemotherapy, the latest success by the Japanese drugmaker to expand its portfolio of such products.

The decision was based on results from Phase II and Phase III clinical trials that included patients undergoing chemotherapy for various types of cancers.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common side effects from the cancer treatment. Akynzeo (netupitant/palonosetron) helps patients manage CINV for up to five days following chemotherapy, Eisai said.

The drug will be marketed and distributed in the U.S. by Eisai and is licensed by Switzerland-based Helsinn Group. Helsinn is currently seeking European approval for the product.

Eisai has been pushing this year to expand its offerings in the CINV market. In May, the FDA expanded the indication for Eisai’s Aloxi (palonosetron HCl) to treat CINV in children ages one month to 17 years. The drug was already approved to treat adult patients. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.