The FDA has taken a red pen to Eisai's application for approval of perampanel for epilepsy patients, handing the Japan-based drugmaker a refusal to file letter for the NDA submitted in May. It's perhaps the latest case of the agency raising the bar and making developers cross all their t's and dot there i's before filing the apps.
Eisai made clear that the refusal to file letter was in no way related to merits of perampanel as an approvable medicine, for which the Japanese pharma is seeking approval to treat partial-onset seizures in epileptics. Yet after a review of the app, the FDA has asked the drugmaker to reformat and reanalyze some data it had submitted to the agency. And the company believes that it can deliver on that request without conducting any new studies.
Eisai follows a growing list of top drugmakers who have been given the somewhat embarrassing refusal to file letters from the FDA. In recent years the agency has delivered them to Novartis, Pfizer, Roche and Gilead. Presumably, these companies are some the best in the business when it comes to ushering drugs through the regulatory process. Yet they are clearly not immune to U.S. regulators high standards for drug applications.
As a Leerink Swann analyst said earlier this year, the fact that Big Pharma outfits have been getting RTFs could be due to FDA Commissioner Margaret Hamburg making sure the agency toes the line on the apps, Pharmalot reported. And the report noted that U.S. regulators have also implemented a program to spot deficiencies in applications early in the review process, another potential reason for an apparent jump in the number of RTFs going to industry heavyweights.
- here's Eisai's release