No­var­tis’ Zol­gens­ma joins grow­ing list of med­i­cines to lose ac­cel­er­at­ed as­sess­ment sta­tus in EU

The EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) re­cent­ly an­nounced its de­ci­sion to re­move No­var­tis’ spinal mus­cu­lar at­ro­phy gene ther­a­py onasemno­gene abepar­vovec from its ac­cel­er­at­ed as­sess­ment pro­gram.

CHMP did not an­nounce its rea­son­ing be­hind the de­ci­sion, which ef­fec­tive­ly means that the treat­ment, ap­proved in the US as Zol­gens­ma and launched at a price of more than $2 mil­lion, will be re­viewed in the EU in 210 days rather than the ac­cel­er­at­ed 150 days. No­var­tis con­firmed that its gene ther­a­py is now un­der stan­dard ap­proval.

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