Against long odds, we demonstrated to the European Medicines Agency the high unmet need and the clinical benefits of FAMPYRA, thereby reversing their initial negative opinion. We obtained conditional EU marketing approval in July 2011 and have also received regulatory approval in Australia and New Zealand. By the end of 2011, FAMPYRA launched in Germany, Denmark, Norway, UK, Iceland and Australia. We have seen initial strong uptake in Germany and hope to build upon this momentum in 2012.
In 2012, we will focus on expanding FAMPYRA's footprint in Europe through additional launches and regulatory filings in more than 20 countries.
1 Heesen C, et al. Mult Scler. 2008; 14: 988–991.
2 Halper J, Perrin Ross, A. Int J MS Care. 2010; 12: 13–16.