IQWiG: 'no additional benefit' for epilepsy drug Fycompa

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said epilepsy drug Fycompa perampanel from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) provides "no additional benefit" over comparators requested by Germany's Federal Joint Committee (G-BA). G-BA requested lamotrigine as a comparator for adjunct therapy and topiramate as a comparator for adjunct therapy when lamotrigine is base therapy. Eisai's submission included data comparing Fycompa as an adjunct therapy to lamotrigine as a base therapy vs. placebo as an adjunct therapy to lamotrigine; IQWiG said the data were "not relevant." IQWiG noted that Eisai also did not include data comparing Fycompa as an adjunctive therapy to topiramate when lamotrigine is base therapy. Eisai has until Jan. 7, 2013, to respond to the preliminary benefit assessment. A final benefit assessment from G-BA is expected in early March 2013. ...