Trobalt retigabine regulatory update

Early next year, Germany's Federal Joint Committee (G-BA) plans to start a new assessment for epilepsy drug Trobalt retigabine from GlaxoSmithKline. The committee was conducting an assessment of Trobalt but decided to restart the assessment process because the indication that was being evaluated for Trobalt no longer corresponds with the drug's approved indication. Earlier this year, EMA restricted use of the drug to last-line therapy in patients with partial epilepsy due to the risk of retinal pigmentation. A new dossier for Trobalt is due by Jan. 14, 2014 (see BioCentury, June 3 & Aug. 5). ...