Eisai has had it with the Drug Enforcement Administration (DEA). The Japanese drugmaker won FDA approval for its new seizure drug, Fycompa, last October. But the DEA still hasn't done its part by classifying it as a controlled substance--and that means the drug can't launch.
So, Eisai sued yesterday, in an attempt to force the DEA to get moving. As The Wall Street Journal reports, the company called the delay "unreasonable and egregious" and asked the U.S. appeals court in the District of Columbia to intervene.
It's the second time Eisai has had to wait on the DEA in recent months. As Arena Pharmaceuticals' ($ARNA) marketing partner on the diet drug Belviq, approved by FDA in June 2012, the drugmaker sat idling, unable to launch, till the DEA finally scheduled the drug in May.
Fycompa and Belviq had to undergo DEA review because regulators saw potential for abuse. The agency assesses that risk and assigns each drug a classification accordingly. Until the DEA speaks on a particular product, the drug can't be sold. And as the Journal points out, the DEA's timeline has steadily grown, to an average of 238 days after FDA approval from 49 days in the late 1990s.
On Belviq, Eisai had to wait 315 days, an interval the company said is the longest ever. For Fycompa, Eisai had expected the DEA to act by July 1. Estimated Fycompa sales lost? Some $8 million by the end of this month, the company told the WSJ. As for Belviq, Eisai and Arena must compete with Vivus' ($VVUS) Qsymia, which launched last year (though it hasn't done much with that first-to-market advantage).
Fycompa hasn't had an easy time of it in Europe, either. Despite the fact that it's a first-in-class treatment, German pricing authorities deemed it no better than already approved drugs--so Eisai pulled it off the market there, unwilling to sell at a cut-rate price.
- read the WSJ piece
- here's Eisai's press release
- see more from FierceBiotech