Sensipar Exclusivity Dispute Back to FDA

Amgen’s suit against FDA over the agency’s denial of six months’ pediatric exclusivity for the company’s Sensipar (cinacalcet) tablets has been placed on hold by a DC federal court judge while the company seeks resolution of its claim through the FDA formal dispute resolution process. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that Amgen says it met the pediatric exclusivity requirement and that the agency “acted contrary to the plain terms of the governing statute by faulting Amgen for its failure to fulfill one criterion of several study requests, when the statute merely requires that the studies ‘fairly respond’ to the agency’s [written request for pediatric studies.]”

The judge’s order includes deadlines for Amgen’s submission to FDA, FDA’s response, and further steps by both sides. Karst says that if FDA again denies Amgen pediatric exclusivity, the parties will likely return to court.