August 12, 2019 / 10:09 PM / 4 months ago

UPDATE 1-Senator Grassley seeks info on Novartis's Zolgensma data issues

(Adds details from letter, background, Novartis comment)

Aug 12 (Reuters) - U.S. Senate Finance Committee Chairman Chuck Grassley has asked Swiss drugmaker Novartis AG to provide details on data manipulation related to its $2 million gene therapy, Zolgensma, by Aug. 23.

The Republican, in a letter dated Aug.9 to the drugmaker's Chief Executive Officer Vasant Narasimhan, asked the company to provide all records on its internal inquiry into Zolgensma data discrepancies. (bit.ly/2Z18Fc3)

Grassley wanted Novartis to submit additional details, including the date when it came to know that it issued manipulated data to the FDA as well as the number of employees terminated in relation to the issue.

Novartis said it has received the Senator's letter and was reviewing the request.

The drugmaker faces potential civil or criminal penalties from the U.S. health regulator, which said last week that some data was manipulated from early testing of Zolgensma, the world's most expensive treatment.

Novartis admitted that it knew about the data discrepancies while it sought approval of its gene therapy, but delayed notifying authorities until it had completed an internal investigation.

Zolgensma, a rival treatment to Biogen Inc's Spinraza, was approved in May as a one-time treatment for spinal muscular atrophy (SMA), the leading genetic cause of death in infants.

Grassley's letter comes as U.S. Senators, including Democratic presidential candidates Bernie Sanders and Elizabeth Warren, sent a letter to the FDA on Friday, urging the agency to use its authority to hold Novartis accountable. (bit.ly/2Z4i3b3)

Reporting by Manojna Maddipatla in Bengaluru; Editing by Arun Koyyur

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