Savient, Gout, and FDA… Back At The Door (SVNT)
Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) is from giving up on its KRYSTEXXA as a gout treatment. This morning the company announced that it has resubmitted its Biologics License Application to the FDA. This has been in the news, particularly since the company announced a secondary offering late last year after the FDA denied this in August and sent shares down 35% at the time. This one even got on the map as an old Jim Cramer favorite.
The resubmission is for KRYSTEXXA to treat chronic gout in patients refractory to conventional therapy, which is effectively in patients who have failed to normalize their levels of serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose. It also for patients where these drugs are contraindicated. The resubmission includes data from three consecutive manufacturing validation batches, additional and improved analytical methods for the control and release of pegloticase API and KRYSTEXXA and other data which are designed to address the issues cited by the FDA in its July 31, 2009 Complete Response Letter (CRL). Also included is a safety update from the remaining studies that were ongoing at the time of the previous 120-Day Safety Update.
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