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Savient resubmits BLA for Krystexxa in treating gout
Monday, March 15 2010 | Comments
What's This?
Savient Pharmaceuticals Inc. resubmitted its Biologics License Application (BLA) to the Food and Drug Administration for Krystexxa (pegloticase) as a treatment for chronic gout in patients whose disease is refractory to conventional therapy. The company filed the resubmission to address the deficiencies and observations raised in a complete response letter it received from the FDA last July. The revised BLA also contains additional materials the agency requested.
In its letter, the FDA requested more safety information on Krystexxa and expressed several concerns with the drug's manufacturing processes, such as differences between the Krystexxa used in clinical trials and the version that would be marketed.
The FDA subsequently indicated that it did not expect additional trials of Krystexxa would be required. It suggested that reverting to and validating the original manufacturing process used to produce the Phase III trial material and making certain changes to the manufacturing process would be adequate to produce a drug substance representative of that used in the trials.
Following the receipt of the complete response letter, Savient announced plans to cut approximately 38 percent of its work force to lower costs and focus on the BLA resubmission.
In its earnings report for the third quarter of 2009, the company said it expected that the restructuring plan would save $2.9 million through the year ending Dec. 31, 2010, net of $1.2 million in severance-related expenses.
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