Zealand Pharma announces new timelines for U.S. FDA decision on iglarlixi
Saturday, August 20, 2016
Zealand announces new timelines for a U.S. FDA decision on iglarlixi, the fixed-ratio combination of lixisenatide (adlyxintm) and lantus(r), for the treatment of type 2 diabetes.
Financial guidance for 2016 remains unchanged.
A U.S. regulatory decision on iglarlixi is now expected before end of November 2016.
FDA requested updated information on pen delivery device for iglarlixi as part of new drug application, which was submitted by Sanofi.
Source : reuters.com
