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German Cost Regulator Rejects Bayer AG (BAY.F) and Regeneron Pharmaceuticals, Inc. (REGN) Eye Drug


3/20/2013 7:50:18 AM

Bayer and Regeneron received a blow last week when Germany's cost effectiveness watchdog turned down their eye disorder drug Eylea after ruling that it did not provide enough benefit compared to current treatments. The German health technology assessment (HTA) body IQWiG released a statement on Friday claiming that, following an assessment of the benefits of Eylea (aflibercept), current data was unable to prove the drug was superior to Novartis' Lucentis (ranibizumab) in the treatment of wet age-related macular degeneration (AMD). IQWiG acknowledged that Bayer and Regeneron had provided data that compared the two treatments, but said this was not an appropriate comparison as Lucentis was not used as described in its recommendation in Europe. Lucentis was approved by the European Medicines Agency (EMA) for wet AMD in 2007 to be administered once a month as an intravitreal injection. This indication was updated in 2011 to only recommend Lucentis until maximum vision is achieved and is stable for three consecutive months. However, in the comparator trials to support the approval of Eylea, Lucentis was given as per its original recommendation and continued to be used by patients once they had achieved maximum vision. This meant the data submitted by Regeneron and Bayer was not reliable and a positive recommendation could not be made, according to IQWiG.

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