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Biotech / Medical : Regeneron Pharmaceuticals

REGN 784.45

-0.4%

Nov 26 3:59 PM EST

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To: Biotech Jim who wrote (1764)	6/8/2015 8:07:15 AM
From: Biotech Jim	of 3559

REGN/SNY Addendum to the FDA AdComm Breifing Document. fda.gov Addendum: Safety data This document is an addendum for the following sections of the briefing document: • Section 9.9.4 – Adverse Events of Special Interest: Neurocognitive Events • Section 9.11 – Cardiovascular Events Confirmed by Adjudication. The original Advisory Committee briefing document includes data for neurocognitive events and CV events as of the data cut-off date of 31 December 2014. This was the cut-off date that we had used for the FDA 4-month safety update report (SUR). We chose this SUR data set so that the data provided in the briefing document would be consistent with the final LONG TERM study data published earlier this year in the New England Journal of Medicine by Robinson et al. However, the FDA has since informed us that they will restrict their presentation at the Advisory Committee meeting to the safety data initially submitted in the BLA application. To avoid confusion, we have decided to do the same. This addendum provides the neurocognitive event and CV event data as of 31 August 2014 as initially submitted in the BLA. For reference, data as of 31 December 2014 provided in the original advisory committee briefing document are provided in this addendum along with the data as of 31 August 2014. As you will see, the differences are small and do not change any of the conclusions in the original briefing document. Addendum: Indication We are also providing a revision to the proposed indication based on the FDA’s comment in their briefing book that alirocumab monotherapy could be used in patients who cannot tolerate statins (see Section 2.1 – Indication).

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