Eisai slams German decision on Fycompa; Takeda files vedolizumab with EMA

The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system in Germany, has that it considers the additional benefit of Japanese drug major Eisai’s (TYO: 4523) epilepsy drug Fycompa (perampanel) unproven when compared to two other treatments as defined by the G-BA. CS PharmaValues NPV Analysts at Credit Suisse have a net present value for Fycompa in Europe is 97.88 yen per share (3% of total) for Eisai.

The decision follows the German Institute for Quality and Efficiency in Health Care (IQWiG) assessment saying that the benefit of perampanel is unproven based on methodological grounds (The Pharma Letter December 19, 2012). Perampanel is the first in an entirely new class of innovative treatment for uncontrolled partial epilepsy with a novel mechanism of action that is different from all other anti-epileptic drugs (AEDs).

Eisai says it “is appalled by the G-BA’s ruling.” The company believes that the G-BA failed to adequately interpret the proven patient-relevant benefits substantiated in the submitted benefit dossier and to responsibly recognize the innovative nature of the new drug in a clinical setting with a highly unmet medical need.