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).

Epileptic seizures are referred to as partial (or focal) seizures if they only affect a small part of the brain, and muscle twitching and cramps are restricted to single regions of the body. However, such seizures may spread across the whole body and are then referred to as "secondary generalization.” Retigabine was approved in Europe last spring as add-on therapy for the treatment of partial seizures with or without secondary generalization in persons aged 18 years and over.