Eisai’s Aloxi Approved by FDA for Pediatric Patients

Japanese drugmaker Eisai said that its antiemetic agent Aloxi (palonosetron HCI) has received FDA approval for an additional indication: the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in children ages 1 month to 17 years.

This is the first product approved for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients one to 6 months old, Eisai said. This is despite the fact that peak cancer occurrence among children happens within the first year of life, they noted.

Eisai’s received exclusive rights to market the drug in the U.S. from Switzerland’s Helsinn Healthcare.

The company said approval was based on a randomized, double-blind, non-inferiority pivotal trial comparing Aloxi with ondansetron in pediatric patients. The primary endpoint — no vomiting, no retching and no antiemesis rescue medication required within 24 hours after chemotherapy — was achieved in 59.4 percent of patients who received Aloxi compared with 58.6 percent of patients who received the ondansetron regimen.

The study established that pediatric patients need a higher palonosetron dose based on weight than adults to prevent CINV, the company said. Aloxi’s pediatric safety profile was consistent with the established profile in adults, the Tokyo-based company noted.

Eisai said its clinical trial data has met the FDA's Written Request requirements for pediatric exclusivity, resulting in an additional six months of U.S. market exclusivity for Aloxi, which expires on October 13, 2015. — Kellen Owings

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