Faced with an­oth­er ethics scan­dal, No­var­tis CEO Vas Narasimhan as­sures an­a­lysts they tried to do 'the right thing'

No­var­tis’ new gene ther­a­py sub­sidiary AveX­is has put up a red flag re­gard­ing the ma­nip­u­la­tion of da­ta used in its quest to ob­tain an FDA ap­proval for the gene ther­a­py Zol­gens­ma, re­cent­ly OK’d for lethal cas­es of spinal mus­cu­lar at­ro­phy and sold now for $2 mil­lion. And the FDA has re­spond­ed by open­ing a probe while threat­en­ing pos­si­ble civ­il and crim­i­nal sanc­tions re­lat­ed to the world’s most ex­pen­sive drug.

The FDA is­sued a state­ment from CBER’s Pe­ter Marks say­ing that “the agency was in­formed by AveX­is Inc., the prod­uct’s man­u­fac­tur­er, about a da­ta ma­nip­u­la­tion is­sue that im­pacts the ac­cu­ra­cy of cer­tain da­ta from prod­uct test­ing per­formed in an­i­mals sub­mit­ted in the bi­o­log­ics li­cense ap­pli­ca­tion (BLA) and re­viewed by the FDA.”

We are al­so aware that AveX­is be­came aware of the is­sue of the da­ta ma­nip­u­la­tion that cre­at­ed in­ac­cu­ra­cies in their BLA be­fore the FDA ap­proved the prod­uct, yet did not in­form the FDA un­til af­ter the prod­uct was ap­proved. The agency will use its full au­thor­i­ties to take ac­tion, if ap­pro­pri­ate, which may in­clude civ­il or crim­i­nal penal­ties.

No­var­tis stock dropped 2.8% on Tues­day.

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