ARTICLE | Clinical News

Trobalt retigabine regulatory update

April 21, 2014 7:00 AM UTC

Germany's Federal Joint Committee (G-BA) issued a preliminary benefit assessment saying that epilepsy drug Trobalt retigabine from GlaxoSmithKline has "no additional benefit" vs. individualized antiepileptic therapy. According to G-BA, GSK did not submit complete, necessary data. The pharma, which does not market Trobalt in Germany, said proving Trobalt's additional benefit vs. the comparator would be "methodologically impossible." Comments on the assessment are due May 6, with a final assessment from G-BA expected in early July.

This is the second assessment for Trobalt in Germany. In 2012, G-BA said the potassium channel opener and potentiator of GABA had no additional benefit, and GSK requested a new benefit assessment (see BioCentury, May 14, 2012 & Jan. 21, 2013). Last year, EMA updated Trobalt's label to restrict its use to last-line therapy in patients with partial epilepsy (see BioCentury, June 3, 2013). ...