REMS, Postmarket Studies Come With Affymax, Takeda Anemia Drug Approval

The FDA granted approval to Affymax and Takeda’s once-monthly anemia treatment Omontys, but has loaded the companies with postmarketing requirements, including two safety studies and a risk evaluation and mitigation strategy (REMS).

Omontys (peginesatide), an injectable erythropoiesis-stimulating agent (ESA), can be marketed to adult chronic kidney disease patients on dialysis.

The drug’s OK comes with multiple postmarket commitments, including an observational study and a randomized controlled trial to evaluate cardiovascular safety and assess long-term safety in adult dialysis patients. Final reports of the observational study and trial must be submitted by 2018 and 2019, respectively, the companies said.

The FDA has made speeding up drug approvals a priority and has created a strong selection of tools to help achieve that goal. From the priority review process, to the accelerated approvals program, to REMS, the agency has strategies at its disposal to avoid snags when getting drugs out to the population.

But none of these can rescue a new drug application that doesn’t satisfy basic FDA requirements. Of the 35 new innovative drugs approved in fiscal 2011, 14 required more than one review cycle. And overall, as few as one in five new drugs ever gets approved.

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