Fampyra fampridine regulatory update
The German Institute for Quality and Efficiency in Health Care (IQWiG) said Fampyra fampridine from Biogen Idec provides no additional benefit over physiotherapy in multiple sclerosis patients with walking disability. According to IQWiG, Biogen Idec only submitted data indirectly comparing Fampyra against physiotherapy. While IQWiG does accept indirect comparisons, the institute said Biogen Idec's data did not meet its requirements for an acceptable indirect comparison. Biogen has until May 23 to respond to the assessment. The Federal Joint Committee (G-BA) will then review IQWiG's recommendations and issue a final benefit assessment for the drug, which is expected in early August. Pricing negotiations would begin after G-BA's final assessment. ...