It seems like that’s all that can be said about the premature announcement of FDA's still-pending approval of Amgen’s platelet drug romiplostim (Nplate).
Business Wire erroneously sent out a press release yesterday morning announcing that the biologic had been approved for the treatment of thrombocytopenia. Amgen quickly retracted the release, saying that the Nplate application was still under FDA review, and Business Wire acknowledged its error.
It's pretty obvious that FDA and Amgen are wrapping up final details on Nplate and that approval is imminent. But that shouldn’t come as much of a surprise, given that FDA was handed a unanimous recommendation for approval by the Oncologic Drugs Advisory Committee in March.
FDA still has more than a week to approve Nplate by its July 23 user fee deadline; the review was extended by three months to allow time for the agency to consider Amgen’s Risk Evaluation & Mitigation Strategies (REMS) plan, which was submitted as a major amendment to the BLA in March.
So what, if anything, can be gleaned from the retracted release? Well, as reported in “The Pink Sheet” DAILY this morning, Amgen’s REMS program for Nplate will include the Network of Experts Understanding and Supporting Nplate and Patients, or NEXUS, program. We’ve written extensively about the lessons learned from the first REMS in The RPM Report; you can access those stories here and here.
But perhaps the best news out of the Nplate slip-up is for branding firms: NEXUS pretty much guarantees that REMS programs (like major clinical trials) will continue to be referred to as acronyms-that-are-not-quite-acronyms. (Some of our favorites include TOUCH, IDEAL and CIMplicity.)
While some might liken that craft to seeing religious figures in pancake batter, we suppose someone has to come up with those clever (silly?) names.
Photo courtesy of Flickr user dejajib under a creative commons license.
Tuesday, July 15, 2008