AveXis Issues Detailed Response to Zolgensma Form 483

Novartis subsidiary AveXis placed the blame for data manipulation over its $2 million spinal muscular atrophy drug Zolgensma squarely on two former senior executives, in a lengthy response to the FDA’s Form 483 inspection observations.

The two executives, Brian and Allan Kaspar, former chief scientific officer and senior vice president for R&D, respectively, were placed on administrative leave in May and were fired for cause in August, the company said.

The many corrective actions listed in the detailed Aug. 23 response include the creation of a Data Integrity Officer role. The company, acquired by Novartis in May 2018, will be fully integrated into the Novartis global quality network.