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Enbrel REMS delays pediatric approval

Executive Summary

Amgen received a "complete response" letter from FDA on Enbrel (etanercept) in pediatric patients with moderate to severe plaque psoriasis, the biotech announces July 24. The tumor necrosis factor inhibitor would be the first FDA-approved treatment for the indication. FDA has requested additional information related to the Risk Evaluation and Mitigation Strategy for Enbrel in pediatric psoriasis, Exec VP-R&D Roger Perlmutter says during a second quarter earnings call July 28. Amgen is also working out a REMS strategy with FDA for the platelet drug Nplate (romiplostim), which had a July 23 user fee date. "REMS programs are becoming increasingly important in our interactions with the FDA," Perlmutter says. FDA is setting precedents with every REMS - a new part of the regulatory process - and has extended or missed several user fee deadlines as a result

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