Ques­tions pile up for No­var­tis as sen­a­tors call on FDA to take ac­tion

Why wait three months to tell the FDA about ma­nip­u­lat­ed da­ta? Why wait two months be­tween doc­u­ment­ing an ini­tial is­sue and open­ing a non­con­for­mance re­port (NCR)? And how harsh­ly will the FDA act?

These ques­tions and more are pil­ing up for No­var­tis, fol­low­ing last week’s an­nounce­ment that the FDA is in­ves­ti­gat­ing the com­pa­ny for ma­nip­u­lat­ing da­ta linked to its $2.1 mil­lion gene ther­a­py Zol­gens­ma (onasemno­gene abepar­vovec-xioi). In Eu­rope, reg­u­la­tors have al­ready pulled the gene ther­a­py’s ac­cel­er­at­ed as­sess­ment for a longer, stan­dard as­sess­ment.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.