USA – FDA: Novartis used faulty data to seek therapy approval

The Food and Drug Administration is threatening to take criminal action against Novartis, saying Tuesday the drugmaker used data it knew was inaccurate in its application for a $2.1 million gene therapy that was approved in May.

“On June 28, following the FDA’s approval of the product, 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 and reviewed by the FDA,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement.

AveXis is the gene therapy subsidiary of Novartis. The FDA said the gene therapy for spinal muscular atrophy should remain on the market, even while it’s still assessing the situation.

“The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties,” Marks added.

U.S.-traded shares of the Swiss drugmaker tumbled 3.6% in early afternoon trading. Biogen, which also produces a spinal muscular atrophy treatment, was up about 1%…