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BRIEF-Amgen submits regulatory applications in US, Europe
July 14, 2017 / 1:16 PM / 3 months ago

BRIEF-Amgen submits regulatory applications in US, Europe

July 14 (Reuters) - Amgen Inc:

* Amgen submits regulatory applications in US and Europe to include overall survival data in kyprolis (carfilzomib) label

* Amgen - data showed kyprolis and dexamethasone reduced risk of death by 21 percent and increased overall survival by 7.6 months versus velcade and dexamethasone​

* Amgen - ‍announced variation to marketing application to EMA to include OS data from phase 3 head-to-head endeavor trial in product info for kyprolis​

* Says ‍adverse events observed in this updated analysis were consistent with those previously reported for endeavor​

* Amgen - submission of SNDA to FDA, variation to marketing application to EMA to include overall survival data from phase 3 kyprolis​ trial Source text for Eikon: Further company coverage:

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