German Trobalt reassessment encounters delays
A spokesperson for Germany's Federal Joint Committee (G-BA) said the committee is slated to discuss later this month whether to continue with its current assessment or restart its assessment of epilepsy drug Trobalt retigabine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). A preliminary assessment from Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) was expected Thursday.
According to the agenda for G-BA's Aug. 15 plenary meeting, the indication being evaluated for Trobalt no longer corresponds with the drug's approved indication. Earlier this year, EMA restricted use of the potassium channel opener and potentiator to last-line therapy in patients with partial epilepsy due to the risk of retinal pigmentation (see BioCentury Extra, May 31). ...