PTC’s muscular dystrophy drug Translarna to get another review in the EU

The Eu­ro­pean Com­mis­sion made the rare de­ci­sion Mon­day not to adopt the neg­a­tive opin­ion of the Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) on the re­new­al of Translar­na’s con­di­tion­al au­tho­riza­tion.

The EC sent the opin­ion back to the CHMP for fur­ther eval­u­a­tion, al­low­ing the Duchenne mus­cu­lar dy­s­tro­phy ther­a­peu­tic to re­main on the mar­ket for now. PTC Ther­a­peu­tics wrote that the EC “asked the CHMP to fur­ther con­sid­er the to­tal­i­ty of ev­i­dence, in­clud­ing da­ta from pa­tient reg­istries and re­al-world ev­i­dence, in a re­vised opin­ion.”

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