Trobalt retigabine regulatory update

The German Institute for Quality and Efficiency in Healthcare (IQWiG) said adjunctive epilepsy drug Trobalt retigabine from GlaxoSmithKline provides "no additional benefit" over comparators. The agency said GSK's submission contained no evaluable data because the pharma selected different comparators than IQWiG.

IQWiG said the pharma did not take advantage of an optional consultation to discuss appropriate comparators with the Federal Joint Committee (G-BA), which commissions IQWiG to conduct product assessments. G-BA chose lamotrigine as a comparator for adjunct therapy, and topiramate as a comparator for adjunct therapy when lamotrigine is base therapy. GSK compared Trobalt with Vimpat lacosamide, which is marketed by UCB Group (Euronext:UCB, Brussels, Belgium). ...