Wednesday, August 27, 2014

UpdatesPlus Heart Failure - Amgen on track to potentially launch Ivabradine for chronic heart failure in the US mid-2015

This alert comes from our UpdatesPlus - Heart Failure servicea regular analysis providing depth information on all key recent events in the area.  To receive further information or instruction on how to access the service please contact
  • Ivabradine (Procoralan) approval was granted to Servier by the EMA in 2005, however outside of the EU, ivabradine has yet to gain FDA approval
  • Servier licensed US rights to Amgen in July 2013.  Amgen has previously commented that NDA filing is targeted for 2014, and that the FDA has awarded ivabradine fast track status
  • We issued an alert earlier this month that Amgen filed its NDA.  At the time we indicated that the FDA would likely expedite review because of the fast track status.  This has now been confirmed lining up review for Q1 2015

Comment:  We previously suggested that an FDA decision could be expected early 2015.  This now appears to be the case with possible launch mid 2015.  Although the speed of development has obvious advantages it should be considered that Amgen will be new to the CV market.  Amgen has previously announced that a CV team will handle the launch of ivabradine as well as its PCSK9 inhibitor Evolocumab.  We expect a BLA to be filed for this second candidate during this quarter and as a result this new CV team could find itself handling 2 major launches in a similar time frame.  Whether this would introduce risks remains to be seen


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