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Data manipulated prior to approval of $ 2.1M medicine




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US regulators want to know why Novartis didn't reveal a problem with testing data until after the $ 2.1 million Swiss medicine manufacturer's therapy was approved. The Food and Drug Administration said Tuesday that the manipulated data involved testing animals, not patients, and that they are confident that the drug, called Zendixma, should remain on the market, the AP reports. The agency said it is investigating and will consider criminal or civil penalties if appropriate. Zwylma was approved in May for children under 2, and became the most expensive treatment ever. It is a one-time treatment for a rare hereditary condition, spinal muscular atrophy, which destroys the baby's muscle control.

The FDA said in a statement that AveXis Inc., the Novartis AG subsidiary producing Zeneverma, told the agency five weeks after the approval of a "data manipulation problem" that resulted in inaccurate information on animal testing. The agency said the company knew about the problem before the FDA approved Z subsequentlyma. The inaccurate data is a small subset of the test information evaluated by the FDA. Acting FDA Commissioner Ned Sharpless tweeted that "the agency will use its full authority to take action." In a statement Tuesday night, Novartis said that after AveXis learned about alleged data manipulation in one animal procedure, the company immediately began investigating. When it had "preliminary conclusions," it shared them with the FDA. Novartis did not say why it did not notify the FDA until it approved Z subsequentlyma.

(Read more Novartis stories.)

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