Eisai adds to chemo side-effects franchise with FDA nod for Akynzeo

Months after launching a regulatory battle to extend exclusivity for two of its best-selling products, Eisai won FDA approval for its Akynzeo drug to treat common side effects in patients undergoing chemotherapy.

The Japanese drugmaker's pill combines two drugs, palonosetron and netupitant, to quell nausea and vomiting in cancer patients on chemotherapy. Approved in 2003 as the intravenous drug Aloxi, palonosetron prevents vomiting during the first 24 hours of chemo, and netupitant, a new drug, treats early chemo-related nausea and nausea that occurs later.

Regulators based their approval on two clinical trials comprising 1,720 participants, which showed that the drug effectively reduced--or in some cases removed--symptoms in chemo patients, the agency said in a release. In the first trial, 98.5% of Akynzeo patients didn't experience any vomiting or require nausea medication during early phases of chemotherapy, compared with 89.7% of patients treated only with palonosetron in its pill form, approved in 2008. The second trial posted similar results.

The FDA blessing comes at a critical moment for Eisai, as the drugmaker fights to hold on to exclusivity of two of its top products and ward off competitors. In August, Eisai sued the FDA for allegedly starting the exclusivity clock too soon for its weight loss drug Belviq, which it markets with Arena Pharmaceuticals ($ARNA), and for its seizure remedy Fycompa.

Both drugs were deemed new chemical entities (NCEs), automatically winning 5 years of exclusive access to the market. But the Drug Enforcement Administration (DEA) took almost a full year after Belviq's FDA approval to send the drug through for controlled substance scheduling and waited even longer to schedule Fycompa, with regulators setting the clock ticking in the meantime, Eisai alleged in its suit.

On other fronts, Eisai's chemo side-effects franchise faces competition from a rival product from Merck ($MRK). Oral Aloxi won FDA approval earlier this year to treat chemo-induced nausea and vomiting in children, and just a month later, Merck's Emend beat placebo at the same use in a late-stage trial in children. Emend is already approved for treating chemo-related nausea and vomiting in adults and had global sales of $507 million in 2013, Reuters notes. Merck plans to ask the FDA to approve the new pediatric formulation of Emend by the end of this year.

- read the FDA release
- here's the Reuters story