BioMarin launches LEMS drug Firdapse in European Union; and Genmab gets conditional approval for Arzerra

California, USA-based BioMarin Pharmaceutical says that Firdapse (3,4-diaminopyridine) is now commercially available in the European Union for the treatment of the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS).

Launching immediately in Germany and the UK, the company expects to subsequently debut Firdapse in all major European markets by the end of 2010. The drug received marketing approval in the EU for the treatment of LEMS in December 2009 and this is the first approved treatment for this indication, thereby conferring orphan drug protection and providing 10 years of market exclusivity in Europe.

"The launch of Firdapse brings the first specifically approved treatment option for LEMS to patients in the EU and marks our fourth commercial product on the market. We look forward to meeting with the FDA [Food and Drug Administration]  in the second quarter of 2010 to determine the necessary regulatory path for Firdapse in the USA, and we also continue to evaluate the best development strategy for this product in other indications in the USA and Europe," said Jean-Jacques Bienaime, chief executive of BioMarin.