No proof of added benefit for GlaxoSmithKline's Trobalt, says IQWiG

In another warning to drugmakers trying to get approval of new drugs under Germany’s AMNOG reform law not to deviate from appropriate comparators specified by the Federal Joint Committee (G-BA), the country’s Institute for Quality and Efficiency in Health Care (IQWiG) examined whether retigabine, UK pharma giant GlaxoSmithKline’s Trobalt, offers an added benefit compared with the present standard therapy, concluding that no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the G-BA and chose a different comparator therapy.

Similar fates have recently befallen Novartis’ hypertension drug Rasilamlo and Pfizer’s Xiapex (collagenase extracted from Clostridium histolyticum) for the treatment of Dupuytren’s contracture (The Pharma Letters February 21 and 14).