Trobalt retigabine regulatory update

Germany's Federal Joint Committee (G-BA) said adjunctive epilepsy drug Trobalt retigabine from GlaxoSmithKline provides no additional benefit over comparators. The decision is in line with a February assessment from the German Institute for Quality and Efficiency in Health Care (IQWiG), which said GSK's submission contained no evaluable data because the pharma selected different comparators (see BioCentury, Feb. 20).

GSK said in a statement that the decision is "unacceptable" because G-BA declined to consider additional data comparing Trobalt to G-BA's chosen comparators of lamotrigine and topiramate that GSK submitted during the formal response period, which ended on March 7. G-BA said that if a dossier is incomplete at the time of its initial submission no additional data can be added to the dossier during the assessment process and the following comment period. G-BA invited GSK to take advantage of its interim regulation allowing companies to request a second evaluation starting 1 year after the release of the final benefit assessment. ...