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10 May 2019

Can a new drug rejected by USFDA, can get EU approval?

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Yes it can be. US and EU regulatory body work independently, without any influence of each other. Review of the new drug submisison will be carried out by merit, irrespective of the outcome of one agency from other.

Recently, we have seen The European Commission approval of Akcea’s Waylivra (volanesorsen), as an adjunct to diet in adult patients with confirmed FCS who are at high risk for pancreatitis and have not responded well enough to diet and triglyceride lowering therapy. The EU is the first market for the new drug.

Previously, as the US FDA turned down its marketing application for Waylivra last August despite a 12 to 8 vote in favour of approval from its own advisory committee a year ago. The FDA had voiced concerns about the drug’s safety, particularly some reductions in blood platelet counts (thrombocytopenia) among patients treated with the antisense agent.

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